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DOH GUIDELINES for LEPTOSPIROSIS for HOSPITALS 2019 Edition
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Page 1: DOH GUIDELINES forthepafp.org/website/wp-content/uploads/2020/11/Lepto...DOH Guidelines for Leptospirosis for Hospitals 2 parts of the body (including the cerebrospinal fluid [CSF]

DOH

GUIDELINES for

LEPTOSPIROSIS

for HOSPITALS

2019 Edition

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DOH GUIDELINES for

LEPTOSPIROSIS for HOSPITALS 2019 Edition

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F O R E W O R D

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TECHNICAL WORKING GROUP

Research Institute for Tropical Medicine

Celia C. Carlos, MD

Arthur Dessi E. Roman, MD

National Kidney and Transplant Institute

Romina A. Danguilan, MD

Mel-Hatra I. Arakama, MD

CONTRIBUTORS

Amang Rodriguez Memorial Medical Center Imelda M. Mateo, MD

Dr.Jose Fabella Memorial Hospital Esmeraldo T. Ilem, MD

East Avenue Medical Center Alfonso G. Nuñez III, MD

Jose R. Reyes Memorial Medical Center Emmanuel F. Montaña Jr., MD

National Center for Mental Health Alan Baquir, MD

National Children’s Hospital Epifania S. Simbul, MD

National Kidney and Transplant Institute Rose Marie R. Liquete, MD

Joselito R. Chavez, MD

Philippine Orthopedic Center Jose Brittanio S. Pujalte Jr., MD

Quirino Memorial Medical Center Evelyn Victoria E. Reside, MD

Rizal Medical Center Relito M. Saquilayan, MD

San Lazaro Hospital Edmundo B. Lopez, MD

Benjamin D. Estrella Jr., MD

Rontgene M. Solante, MD

Tondo Medical Center Maria Isabelita M. Estrella, MD

Dr. Jose N. Rodriguez Memorial Hospital Alfonso Victorino H. Famaran, MD

Las Piñas General Hospital and Rodrigo H. Hao, MD

Satellite Trauma Center

San Lorenzo Ruiz Women’s Hospital Marilou T. Nery, MD

Valenzuela Medical Center Maria Estrella B. Litam, MD

DOH-TRC Bicutan Alfonso A. Villaroman, MD

DOH-NCR Corazon I. Flores, MD

Ma. Paz P. Corrales, MD

DOH-FICT NCR Emmanuel A. Tiongson, MD

Ruben C. Flores, MD

Francisco A. Valdez, MD

A Project of FICT Team NCR in cooperation with NKTI under the supervision of

Asec. Elmer G. Punzalan.

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TABLE OF CONTENTS

Chapter 1: MANAGEMENT PROTOCOL FOR LEPTOSPIROSIS

I. Introduction 1 II. Criteria for Diagnosis 5 III. Indications for Admission and Guidelines on

Site-of-Care Decisions 5

IV. Laboratory Work Up Leptospiral Tests 7

Non-Leptospiral Tests 8 V. General Guidelines in the Management of Leptospirosis 9 VI. Antibiotic Management 9 VII. Steroid Therapy 11 VIII. Pulmonary Complications of Leptospirosis

Diagnosis of Pulmonary Complications of Leptospirosis 11 Management of Pulmonary Complications of Leptospirosis 12 Extracorporeal Membrane Oxygenation in leptospirosis 15

IX. Renal Complications of Leptospirosis 15 X. Prevention and Control 18 XI. Chemoprophylaxis Pre-exposure Prophylaxis 18 Post-exposure Prophylaxis 19 XII. References 20 Appendices Appendix A. Modified Faine’s Criteria (2012) 21 Appendix B. Guidelines in Specimen Collection, Storage, Transport and Submission 22

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Chapter 2: UPSURGE POLICIES AND PROCEDURES

I. Statement of Purpose and Scope

Purpose 25

Scope 25

II. Key Policies

Criteria for Activation of Leptospirosis Emergency Policy 25

Person Responsible for Activation of the Leptospirosis Upsurge Policy 26

During Office Hours 26

After Office Hours 27

Activation of the Leptospirosis Upsurge Management Team 27

Critical Bed Status Procedure 28

Standards for Admission of Leptospirosis Patients 28

III. Roles and Responsibilities of the Various Departments/ Divisions/Sections

in the Management of a Leptospirosis Upsurge

Emergency Room 29

Division of Internal Medicine 30

Divisions of Adult and Pediatric Nephrology 31

HEMB Team 32

Division of Organ Transplantation and Vascular Surgery 32

Department of Pathology and Laboratory Medicine 32

Section of Pulmonary Medicine 32

Department of Medical Imaging and Therapeutic Radiology 32

Nursing Services 33

Hemodialysis Unit 33

Peritoneal Dialysis Unit 34

Infection Prevention and Control Committee 35

Medical Social Services Division 35

Pharmacy Division 35

Housekeeping Section 36

Procurement and Supply Management Divisions 36

Central Supply and Sterilization Unit 37

Billing and Claims Division 37

Admitting and Discharge Section 37

Information Resource Management Division 38

Nutrition and Dietetics Division 38

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IV. Setting up a Leptospirosis Ward 39

V. Staffing Requirements in the Leptospirosis Ward

Medical Staffing 40

Nurses Staffing 41

VI. Health Care Provider Network 42

VII. Antibiotic Prophylaxis for Leptospirosis

For Adults 43

For Pregnant Women 43

For Children 43

Appendices

Appendix A. Treatment Algorithm for Leptospirosis 45

Appendix B. Leptospirosis Prophylaxis Survey 47

Appendix C. Treatment Algorithm for Leptospirosis (Pediatric Patients) 48

Appendix D. Leptospirosis Census Format for Reporting 51

Appendix E. Criteria for Assisted Ventilation for Leptospirosis Patients 52

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Chapter 1: MANAGEMENT PROTOCOL FOR LEPTOSPIROSIS

I. INTRODUCTION

Leptospirosis is a zoonotic infection caused by pathogenic spirochetes of the

genus Leptospira. Ten (10) out of the 22 identified species under this genus are

considered pathogenic, while the remaining 7 and 5 are non-pathogenic, free-living

saprophytes (e.g. Leptospira biflexa) or of unclear pathogenicity, respectively.1 An

older system has been used to classify them into serovars (based on serology) so

isolates are currently identified using two systems, e.g. Leptospira

icterohemorrhagiae serovar manilae. Over 250 serotypes of pathogenic leptospires

have been recognized and the severe form of leptospirosis have been reported to

be caused by all of these.2 Leptospira icterohaemorrhagiae, by far, has been

commonly associated with severe disease. In the Philippines, earlier studies

reported that the major serovars affecting humans in Metro Manila and neighboring

provinces were Manilae, Losbanos, Tarassovi, and Poi.3

In Philippines, leptospirosis tends to occur frequently in urban flood-prone

areas such as Metro Manila. This disease gained much attention after an outbreak

following typhoon Ondoy in October of 2009. About two weeks following this heavy

rainfall typhoon that left many areas of Metro Manila flooded, the Department of

Health reported 2,894 probable and confirmed cases of leptospirosis with 210

deaths.4

From January 1, 2018 to December 31, 2018, a total of 5,232 cases were

reported to the Department of Health with a case fatality rate of 9.65%. This is a

71% increase in the total number of cases compared to 2017.5 In fact, in July of

2018, the Department of Health has declared an outbreak of leptospirosis in certain

areas of Metro Manila. Outbreaks of leptospirosis in the Philippines are expected to

occur with increasing incidents of heavy rainfall, rapid urbanization (dramatic

increase in populations), deforestation, increasing number of flood-prone areas,

poor infrastructures, among many other factors.

Leptospirosis is primarily a disease of domesticated and wild animals. Humans

are infected through direct and indirect contact with these animals. The source of

infection is water or soil contaminated with infected urine, infected urine or tissues

from infected animals. The leptospires enter through cuts and abrasions in the skin

or mucosal surfaces, the conjunctiva, or by inhalation (into the lungs) of droplets or

aerosols of fluid containing leptospires. After penetrating intact mucous membranes

or abraded skin, leptospires enter the blood stream and are rapidly carried to all

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parts of the body (including the cerebrospinal fluid [CSF] and the eyes) presenting

as an acute, systemic disease is characterized by extensive vasculitis.

The incubation generally is 5-14 days but a range of 2 to 30 days has been

noted. The incubation period does not vary significantly among serotypes. It may

present as influenza-like illness with headache and myalgia in its mild form and may

present with jaundice, renal dysfunction and hemorrhage (Weil’s Syndrome) when it

presents as severe form.

Leptospirosis presents in two (2) forms: anicteric (mild) or icteric (severe)

leptospirosis. Anicteric (mild) leptospirosis is often characterized by abrupt onset

of fever, headache, severe muscle aches, malaise and prostration. High intermittent

fever, chills, persistent headache, severe myalgias, abdominal pain and nausea and

vomiting persist for 4-7 days. Death almost NEVER occurs during this stage. In

anicteric infections, the second stage may not occur. On the other hand, icteric

(severe) leptospirosis or Weil Syndrome may present with impaired renal and

hepatic function, hemorrhage, vascular collapse, and even severe alterations in

consciousness. This form has a high mortality rate.

The clinical course of leptospirosis varies but it is generally predictable. Both

forms of leptospirosis follow a biphasic course:

1. The LEPTOSPIREMIC PHASE (or ACUTE stage) is characterized by an

acute systemic infection. The onset of symptoms is abrupt and resolves

after 4-7 days. Symptomatic improvement and lysis of the fever coincide

with the disappearance of leptospires from the blood, cerebrospinal fluid

and all other tissue with the EXCEPTION of the aqueous humor (resolves

in 4-30 days) and renal parenchyma (persists for 1-4 weeks in the urine).

Antibody titers to leptospires develop rapidly. This immune response

heralds the second or immune stage of the illness.

2. The IMMUNE PHASE (sometimes LEPTOSPIRURIC PHASE,

CONVALESCENT STAGE) is the second stage and lasts 4-30 days.

Occasionally, there is a brief asymptomatic period of 2-3 days between the

two stages. Leptospiruria continues for 1 week to 1 month. Generally, this

phase is not affected by antibiotic therapy. This phase is characterized by

the presence of circulating antibody and development of meningitis, uveitis,

rash, and (in severe cases) hepatic and renal involvement. In icteric cases,

leptospires can sometimes be isolated from the blood for 24-48 hours after

the appearance of jaundice.1

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In the Philippines, majority of the symptoms of Leptospirosis is non-specific,

which indicates that the initial impression could be viral rather than bacterial. Table 1

lists down the percentage frequencies of signs and symptoms of leptospirosis seen

in our local setting. A comparison of two studies from the Philippine 2009 outbreak

reported that the most common clinical features include fever, myalgia, conjunctival

suffusion, malaise, headache, abdominal pain, oliguria, and jaundice.

Table 1. Clinical Features of Leptospirosis after a flood, National Capital Region, 2009

Sign or Symptom 9 Manila Hospitals, 20096 San Lazaro Hospital, 20097

Number of patients 259 confirmed leptospirosis cases 471 cases

Fever 98.5 100*

Myalgia/calf-tenderness 78.1 76.7

Malaise 74.9 44.2

Headache 55.6 52.2

Chills 44.8 NR

Conjunctival suffusion 59.3 78.1

Hypotension 23.6 NR

Abdominal pain 52.7 61.2

Nausea/vomiting 52.0 57.8

Diarrhea 39.0 40.8

Jaundice 38.0 47.8

GI bleeding 16.1 NR

Oliguria 56.6 60.7

Hematuria 22.3 33.1

Cough 30.5 17.6

Dyspnea 21.6 NR

Crackles/rales 23.3 NR

Hemoptysis 14.9 3.2

Hemorrhagic signs 14.6 0.4

*part of inclusion criteria; NR – no report

These clinical findings are consistent with prior local studies done in Metro

Manila since the 1970s (Table 2).

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II. CRITERIA FOR DIAGNOSIS

Leptospirosis should be suspected in an individual with:

An acute febrile illness of at least 2 days AND

Two or more of the following symptoms: myalgia, calf tenderness,

conjunctival suffusion, chills, abdominal pain, headache, jaundice, or

oliguria AND

Any risk factor for acquiring the disease which includes:

- residing in a flooded area

- wading or swimming in floods and contaminated water, with or

without cuts or wounds

- contact with animal fluids especially carcass

- ingestion of contaminated water

A checklist for diagnosing leptospirosis for frontliners have been developed

(See Appendix A). The checklist consists of three parts: Clinical data,

Epidemiologic factors and Bacteriologic and laboratory findings. Using paired MAT

as the gold standard, the estimated sensitivity and specificity of the WHO criteria

were 33% and 66% respectively.9 Studies on the clinical utility of this criteria are

were probably limited by the small sample size.

III. INDICATIONS FOR ADMISSION AND GUIDELINES ON

SITE-OF-CARE DECISIONS

Patients with suspected leptospirosis presenting with MILD symptoms can be

managed on an OUT-PATIENT SETTING. These include patients with stable vital

signs, anicteric sclerae, no jaundice, with good urine output, no evidence of

meningismus/ meningeal irritation, no dyspnea, no tachypnea, no hemoptysis, no

bleeding, not in sepsis / septic shock, and can take oral medications.

On the other hand, patients with suspected MODERATE to SEVERE

LEPTOSPIROSIS should be admitted in a healthcare facility for proper diagnosis

and appropriate monitoring and management. The presence of the following signs

and symptoms will classify a patient to have moderate to severe leptospirosis and

will require admission:

Unstable vital signs

Jaundice / Icteric sclerae

Abdominal pain

Nausea, vomiting and diarrhea

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Oliguria or anuria

Bleeding

Meningismus / meningeal irritation

Sepsis / septic shock

Altered mental status

Difficulty of breathing or hemoptysis

Patients with leptospirosis who are suspected to have pulmonary

complications such as pulmonary hemorrhage or acute respiratory distress

syndrome (ARDS) require special attention because these conditions have been

consistently associated with increased mortality. These patients present with

dyspnea, tachypnea, chest x-ray findings of localized or multilobar infiltrates or

pleural effusion. The decision to admit a leptospirosis patient with pulmonary

complications will depend on the level of hypoxemia (see Table 6).

Moderate hypoxemia: 100<PaO2/FiO2<200 with PEEP≥ 5 cmH2O

Severe Hypoxemia: PaO2/FiO2 < 100 with PEEP ≥ 10cmH2O

Patients with moderate to severe hypoxemia need to be admitted to the

INTENSIVE CARE UNIT for closer monitoring and/or invasive ventilation. Patients

with mild hypoxemia may be admitted in a step down unit or monitored closely in the

wards.

IV. LABORATORY WORK UP

Given the generally low sensitivity and long turnaround times of diagnostics for

leptospirosis, it is not necessary to confirm the diagnosis or wait for the result of

these tests before initiating treatment. Clinical diagnosis especially in the context of

an epidemiologic risk factor and a high index of suspicion are more important. Early

recognition and treatment are important to prevent complications of the severe

disease and mortality. However, if definitive or confirmatory diagnosis is warranted

in suspected cases and for epidemiological and public health reasons, these are the

locally available diagnostic tests for leptospirosis.

The DEFINITIVE diagnosis depends on laboratory findings. Criteria for definite

diagnosis of leptospirosis are either:

Isolation of the leptospires from the patient’s body fluid or tissue OR

Seroconversion or a rise in antibody titer in the microscopic agglutination test

(MAT) in the presence of compatible clinical illness

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PRESUMPTIVE diagnosis of Leptospirosis may be based on the following

findings:

positive dark field examination;

presentation of clinical symptoms that are compatible with leptospirosis and a

microscopic agglutination titer of 1:100 or greater;

a positive macroscopic agglutination slide test reaction on a single specimen

obtained after the onset of symptoms; and

stable microscopic agglutination titer of 1:100 or greater in two or more serum

specimens obtained after the onset of symptoms

A. LEPTOSPIRAL TESTS

1. Microbiologic Test: Culture Method (definitive)

Culture of leptospires can be done using blood or cerebrospinal fluid (CSF)

obtained during the septicemic stage of illness or urine during the immune

and convalescent stage. Additionally, tissue sections obtained by biopsy or

at necropsy, can be submitted for culture of Leptospira. The media used

for culture are Fletcher semisolid medium or Ellinghausen-McCullough -

Johnson-Harris (EMJH) semisolid medium or Tween 80 - albumin medium

(OAC) or Korthoff medium. Cultures are incubated at 28-30oC in the dark

for 6 weeks or longer.

2. Microbiologic Test: Non-culture Method

a. Dark field microscopy – recommended as an aid that may suggest BUT

NOT establish the diagnosis of Leptospirosis

b. PCR for detection of leptospiral nucleic acid in blood or urine (definitive)

3. Serologic Tests

a. Microscopic Agglutination Test (MAT) – detects agglutinating antibodies

against live leptospires using darkfield microscopy. The 21-serovar MAT

is considered the "reference standard" or cornerstone of serodiagnosis

of leptospirosis. However, a genus-specific MAT using a non-

pathogenic Leptospira patoc I strain are being performed by some

centers.

Interpretation:

Single specimen: Titer > 1:800 (probable)

Paired specimen (using acute and convalescent sera): four-fold increase

(definitive)

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b. Rapid leptospiral diagnostic kits (i.e. immunochromatographic tests or

ICTs) - useful rapid tests in the early diagnosis of leptospirosis among

patients with compatible signs and symptoms. There is an increasing

number of tertiary healthcare facilities that are offering these rapid tests

already.

c. IgM ELISA- simple, with acceptable sensitivity that is quite variable

depending on the method of ELISA performed

Table 3. Appropriate timing of Specimen collection for specific leptospiral tests Timing

(from onset of illness) 0-7 days 7-14 days 14-28 days

Specimen and leptospiral test

CSF for culture or darkfield microscopy

Dialysate for leptospiral culture

Heparinized blood for culture and or PCR

Serum (acute specimen) for MAT

Serum for serologic tests (rapid ICTs, IgM ELISA) and MAT (convalescent specimen)

Urine for culture

Refer to Annex B: Guidelines on Specimen collection, storage and transport

for leptospiral tests.

B. NON-LEPTOSPIRA TEST

a. MILD

1. CBC with quantitative platelet count

2. Urinalysis

3. BUN and Creatinine

4. Liver function tests (SGPT, SGOT)

b. MODERATE to SEVERE (request each test if clinically indicated)

1. Serum sodium and potassium

2. Bilirubins (Total Bilirubin, direct and indirect bilirubin)

3. PT/PTT

4. Total protein with A/G, Alkaline phosphatase

5. Chest X-ray

6. 12-Lead ECG

7. Arterial blood gas (ABG) - severe metabolic acidosis (ph< 7.2,

HCO3 <10) and hypoxemia (PaO2 < 60 mmHg, SaO2 < 90%, PF ratio

<250)

8. Total CPK with fractionated CPK-MM determination

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V. GENERAL GUIDELINES IN THE MANAGEMENT OF LEPTOSPIROSIS

Most cases of leptospirosis will be mild and self-limited. A suspicion of

leptospirosis should warrant management as such even without evidence from

leptospiral diagnostics.

Supportive management with hydration and analgesic/antipyretic therapy with

paracetamol are recommended.

Correct electrolyte derangements.

Knowledge on the clinical indicators of progression from an undifferentiated

fever to severe leptospiral disease is very limited. Thus, it is recommended

that any illness [regardless of severity, duration or phase of the disease] that

prompts a patient to seek medical consult and leptospirosis is suspected,

antibiotic therapy should be administered to shorten the duration of illness

and reduce shedding of organisms in the urine.

When the disease is classified as severe, the management is generally the

same as in the management of organ failure from sepsis. Supportive care

with renal replacement therapy, ventilatory support, and blood products may

be required. Consequently, timely referrals to specialists and facilities who

can provide such services are also recommended to prevent delays and

progression of anticipated complications.

The subsequent chapters will discuss the specific recommendations in the

various aspects of leptospirosis management.

VI. ANTIBIOTIC MANAGEMENT

All patients with suspected leptospirosis should be started on antimicrobial

therapy regardless of the phase of the disease of duration of symptoms to shorten

the duration of illness. While there is insufficient evidence on the use of antibiotics

in preventing death from leptospirosis, its use has been shown to have beneficial

effects on several clinically relevant and important outcomes (e.g. decreased the

duration of clinical illness by 2-4 days).10

Treatment with effective antibiotics should be initiated as soon as the

diagnosis of leptospirosis is suspected. Antibiotic administration should not be

delayed regardless of the need for renal replacement therapy.

Doxycycline 5 mg/kg/day PO in 2 divided doses (max 200mg/day) x 1 week.

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Table 4. Recommended Antibiotic Regimens for Leptospirosis

MILD LEPTOSPIROSIS

ADULT CHILDREN

First

line

Doxycycline 100 mg BID PO for 10 days

Amoxicillin 30-50 mg/kg/day in 3 divided doses. Maximum of 2 grams per day

Alte

rna

tive

Amoxicillin 500mg QID or 1g q8h

Azithromycin dihydrate 1 g initially, followed by 500 mg OD for 2 more days

Erythromycin 10 mg/kg/day orally in four divided doses for 1 week

SEVERE LEPTOSPIROSIS (WEIL SYNDROME)

ADULT CHILDREN

Prim

ary

reg

ime

n Penicillin G 1.5 million units IV q 6

hrs for 7 days

Ceftriaxone 1gm q24h for 7 days

Aqueous penicillin G 6-8 million U/m2/day in 6 divided doses for 1 week

Ampicillin 100 mg/kg/day IV every 6 hours

Alte

rna

tive

Ampicillin 0.5-1.0 gm q6h

Azithromycin dihydrate 500 mg OD for 5 days

Cefotaxime 1 gm q6h

Tetracycline 25-50 mg/kg/day orally in four divided doses or IV tetracycline 10-20mg/kg/day IV in four divided doses, max 3 g/day, avoid in children < 9 years

Doxycycline 5 mg/kg/day PO in 2 divided doses (max 200mg/day) x 1 week

Ampicillin 100 mg/kg/day IV every 6 hours or

Erythromycin 10 mg/kg/day orally in four divided doses for 1 week

Note: Step-down therapy can be instituted once patient is clinically stable and able to tolerate oral medication. Any oral antibiotic can be selected.

Table 5. Dosage of Antibiotics in Adults with Renal Impairment

Antibiotic Dose for Normal Renal Function

Adjustment for renal failure Estimated creatinine clearance (CrCl), ml/min

50-90 10-50 <10

Amoxicillin 500mg q6h or 1g q8h Q8h Q8-12h Q24h

Ampicillin 0.5-1gm q6h Q6h Q6-12h Q12-24h

Azithromycin Dehydrate

500 mg OD No dose adjustment

Cefotaxime 1 gm q6h Q8-12h Q12-24h Q24h

Ceftriaxone 1 gm q24h No dose adjustment

Doxycycline 100mg BID No dose adjustment

Penicillin G 1.5 MU q6h No dose adjustment

Table adapted from: Collaborative Statement of the Philippine Society for Microbiology and Infectious Diseases, Philippine Society of Nephrology and the Philippine College of Chest Physicians Council on Critical Care and Pulmonary Vascular Diseases. (2010). The Philippine Clinical Practice Guidelines on the Diagnosis, Treatment and Prevention of Leptospirosis in Adults 2010.

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VII. STEROID THERAPY

Steroids have been reported to reduce or delay the need for ventilator support,

improve PTT or mortality among patients with leptospirosis. While the evidence for

its use is not overwhelming, steroid therapy has found relevance in clinical practice

given the devastating complications of severe leptospirosis, particularly pulmonary

hemorrhage. Thus, steroid therapy is suggested for:

(1) patients at high-risk of pulmonary hemorrhage, and

(2) AKI PLUS any of the following:

platelet count <100

MAP <65 mmHg

Prolonged PT/PTT

Need for inotropes

If there is a decision to use steroids for such patients, it should be initiated as

soon as the first signs and symptoms of pulmonary leptospirosis is detected (e.g.

tachypnea, hemoptysis, dyspnea). The following regimens have been used:

a. Methylprednisolone at a dose of 500 mg IV/day for 3 days, with the first dose

given as bolus within the first 12 hours of onset of respiratory involvement.

b. For those with renal failure, methylprednisolone 500mg IV after HD OD x 3 days.

After 3rd MP dose or after any episode of hemoptysis, give Cyclophosphamide

1g IV as a single dose after HD.

VIII. PULMONARY COMPLICATIONS OF LEPTOSPIROSIS

Pulmonary hemorrhage and Acute Respiratory Distress Syndrome (ARDS) are

the two most common pulmonary complications of leptospirosis. They are usually

associated with worse prognosis and high mortality.

A. Diagnosis of pulmonary complications of leptospirosis

Pulmonary symptoms usually appear between the 4th and 6th day of

disease. Significant risk factors for pulmonary complications are delayed

antibiotic treatment and thrombocytopenia at the onset of the disease.

Pulmonary involvement should be suspected in a leptospirosis patient with the

following:

Tachypnea (RR > 30 breaths/minue)

Cough

Hemoptysis

Dyspnea

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On top of the clinical factors, findings from important laboratory tests aid in the

diagnosis of ARDS. The severity of pulmonary involvement can be assessed by

abnormalities on chest radiograph and arterial blood gas.

1. Radiographic findings commonly accompany pulmonary symptoms. All

patients have bilateral pulmonary infiltration and maybe seen as early as the

first 24 hours of the systemic stage of leptospirosis.

2. Hypoxemia and hypocarbia are common blood gas abnormalities. Elevated

PCO2 is seen in severe cases. Continuous monitoring of oxygen saturation is

recommended in the presence of pulmonary complications.

The table below are parameters that can be used for the diagnosis of ARDS

and for risk stratification to identify site-of-care, particularly the level of oxygenation.

Table 6. American-European Consensus Conference Criteria for ARDS11

Timing Within 1 week of a known clinical insult or new/worsening respiratory symptoms

Origin of Edema Respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e.g., echocardiography) to

exclude hydrostatic edema if no risk factor present

Mild Moderate Severe

Oxygenation 200<PaO2/FiO2<300 with PEEP or CPAP≥ 5

cmH2O

100<PaO2/FiO2<200 with PEEP≥ 5

cmH2O

PaO2/FiO2 < 100 with PEEP ≥ 10cmH2O

Chest Imaging Bilateral opacities-not fully explained by effusions, lobar collapse, masses

Table adapted from: ARDS Definition Task Force, Ranieri, V. M., Rubenfeld, G. D., Thompson, B. T., Ferguson, N. D., Caldwell, E., Slutsky, A. S. (2012). Acute Respiratory Distress Syndrome. JAMA, 307(23), 2526–2533. https://doi.org/10.1001/jama.2012.5669

B. Management of pulmonary complications of leptospirosis

Initiate steroid therapy as soon as pulmonary involvement is recognized

Initiate either invasive (mechanical ventilation) or noninvasive ventilation

(bipap) if there are bilateral infiltrates on chest radiograph and PaO2/FiO2 is

<300 or SaO2 is less than 90% (Refer to Figure 1).

Referral to a pulmonologist is recommended.

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Figure 1. Algorithm for the Diagnosis and Management of Leptospirosis with Pulmonary

Complications

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Non-invasive ventilation (NIV) vs. Invasive ventilation

A trial of NIV can be done in most patients who do not require emergent

intubation. The presence of the following conditions, however, are contrainidication

to NIV and therefore warrant invasive ventilation:

Table 7. Contraindications To Non-Invasive Positive Pressure Ventilation12

Non-respiratory organ failure that is acutely life-threatening

Severe encephalopathy (eg, GCS <10)

Severe upper gastrointestinal bleeding

Hemodynamic instability or unstable cardiac arrhythmia

Facial or neurological surgery, trauma, or deformity

Upper airway obstruction

Inability to cooperate/protect airway

Inability to clear secretions

High risk for aspiration

Table adapted from: International Consensus Conferences in Intensive Care Medicine: Noninvasive positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care Med 2001; 163:283.

Recommended initial non-invasive ventilator setting are as follow: inspiratory

positive airway pressure (IPAP) of 10cmH20, and expiratory positive airway

pressure (EPAP) of 4-5cmH20 = Pressure support level 5 – 6 cmH20. Target tidal

volume of 6-8 mls/Kg (ideal body weight) is aimed for all adult patient. Optimal

noninvasive positive pressure ventilation (NPPV) is the lowest pressure and lowest

Fio2 that achieved SaO2 of 90% or PaO2 of 60mmHg without further clinical

deterioration.

Recommended initial mechanical ventilator settings are as follows:

assist/control mode, utilizing low tidal volume at 6ml/kg body weight, positive end

expiratory pressure (PEEP) of 5cmH2O, FiO2 of 100% and respiratory rate of

25/min. FiO2 and PEEP should be adjusted accordingly to maintain SaO2 ≥90%. If

there are facilities available to measure plateau pressure, it should be maintained at

≤ 30cmH2O. Respiratory rate should also be adjusted according to the patient’s rate

to avoid asynchrony.

Prone positioning is recommended in patient with moderate to severe form of

hypoxemia (PaO2/FiO2 < 150 mm Hg) ideally within the first 48 hrs of ARDS

recognition.

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This maneuver requires 3-5 people, paying close attention to endotracheal

tube (ETT) and central lines. Make sure that patient has an empty stomach. Steps

in prone positioning:

1. Pre-oxygenation

2. Suction endotracheal tube and oral cavity

3. Remove ECG leads and reattach to back after shifting position.

4. Turn over the patient to the prone position.

5. Do repeated zeroing of hemodynamic transducers

6. Support and frequently reposition pressure points: face, shoulder, anterior

pelvis

Successful trials evaluating prone positioning in ARDS used at least 16 hours

of daily proning. When PaO2/FiO2 remained > 150 mm Hg 4 h after supinating

(with PEEP < 10 cm H2O and FiO2 < 0.6), stop prone positioning.

C. Extracorporeal Membrane Oxygenation (ECMO) in leptospirosis

The benefits of ECMO use in severe pulmonary form of leptospirosis and

associated ARDS are still under evaluation.

ECMO has been used more extensively as a potential bridge therapy in

patients with severe ARDS and/or massive hemoptysis.

The best outcome in ECMO for adult respiratory failure occurs when ECMO is

instituted early after the onset (1-2 days).

ECMO is done in a highly specialized center with a trained multi-disciplinary

team. Should ECMO be considered, prompt referral and close coordination

should be done to such centers who can perform the procedure.

IX. RENAL COMPLICATIONS OF LEPTOSPIROSIS

Renal complications of leptospirosis may present in a spectrum which may

span from sterile pyuria , tea colored urine, mild proteinuria to severe anuric acute

renal failure.

Commonly it may present as non-oliguric renal failure with mild hypokalemia.

Oliguria with hyperkalemia may reflect the severity of AKI and may connote poor

prognosis. Oliguria is defined as urine output < 0.5 mL/kg/hr or <400mL/day or

a self-report of decreased or no urine output within the last 12 hours.

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The following are the list of diagnostic tests that should be performed when

AKI is suspected:

CBC with platelet count

BUN, creatinine, sodium, potassium, AST, ALT, bilirubins

Urinalysis

Chest x-ray – check for congestion and/or signs of pulmonary hemorrhage

The algorithm below (Figure 2) is a guide in the management of leptospirosis patients that present with oliguria.

The recommended initial fluid resuscitation for Leptospirosis patient is

Balanced crystalloids. If potassium is in the high normal value or with hyperkalemia,

Isotonic saline is recommended. Hydroxyethyl starch should be NOT be given

because it is associated with increased risk of Acute Kidney Injury, need for Renal

Replacement and mortality.

The recommended initial fluid resuscitation rate is 20ml/kg/h or 500ml of crystalloids

within 15- 30mins Patients with Leptospirosis are prone to ARDS due to

downregulation of the Na transport via Epithelial Sodium Channel (ENaC),

NaKATPase as well as decrease in Aquaporin P5.

Any one of the following are indications for dialysis:

Uremic symptoms- nausea, vomiting, altered mental status, seizure, coma

pH 3 mg/dl in ABG

Serum K >5 meq in an oliguric patient

ARDS, pulmonary hemorrhage (GRADE: moderate)

Hemodialysis is preferred over peritoneal dialysis in patients with AKI secondary to

Leptospirosis. The latter is a valid option if hemodialysis machine is not readily

available.

Daily dialysis is suggested to maintain strict control of azotemia and fluid volume

which can improve survival for those patients with severe Leptospirosis especially if

with pulmonary hemorrhage.

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X. PREVENTION AND CONTROL

A. Hygienic conditions should be encouraged in slaughterhouses, farmyard

buildings and bathing pools

B. Avoidance of exposure to urine and tissues from infected animals such as

wading in flooded areas. Likewise, activities in possible contaminated bodies

of water should be prevented.

C. Vaccination of animals against leptospirosis

D. Rodent control

E. When a potential exposure to contaminated water is anticipated, individuals

should wear protective clothing (boots, gloves, spectacles), cover skin

lesions with waterproof dressings, wash or shower after exposure to

contaminated water, and wash and clean wounds.

F. Avoid drinking water from possible contaminated water sources.

G. Chemoprophylaxis (see next section)

XI. CHEMOPROPHYLAXIS

The use of chemoprophylaxis requires prior consult with a physician. It should

not be taken unless prescribed and fully explained by a physician, including

common side-effects and contraindications. Since antibiotic prophylaxis is not 100%

effective, individuals should continue to monitor themselves for fever and other flu-

like symptoms and should continue to wear personal protective measures when

contact with contaminated water is anticipated.

A. Pre-exposure Prophylaxis

Pre-exposure antibiotic prophylaxis is NOT ROUTINELY RECOMMENDED.

However, this may be considered for short-term exposures in those individuals who

intend to visit highly endemic areas AND are likely to get exposed, including but not

limited to:

Travelers

Soldiers

People who engage in water-related recreational and occupational

activities

Disaster relief workers deployed to flooded or post-typhoon areas

Doxycycline 200mg orally once a week, to begin 1 to 2 days before exposure

and continued throughout the period of exposure.

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B. Post-exposure prophylaxis

Post-exposure prophylaxis is given following contact with contaminated

sources such as flood water, animal carcasses, infected body fluids, etc. The post-

exposure prophylactic regimens depends on the risk for leptospirosis following the

exposure (see Table 7).

Table 8. Post-exposure prophylaxis for leptospirosis in adults and children ADULTS

MILD MODERATE HIGH RISK

single exposure, non-mucosal, no breaks in the skin

mucosal exposure, presence or wound

When there is repeated or continuous exposure

Doxycycline 200mg single dose, immediately within 24 to 72 hours

from exposure

Doxycycline 200 mg once daily for 3-5 days to be started

immediately within 24 to 72 hours from exposure

Doxycycline 200 mg once weekly until the end of

exposure

CHILDREN13

First-line: Doxycycline 4 mg/kg single dose, max dose: 200 mg

Alternative: Azithromycin 10 mg/kg single dose, max dose: 500 mg*

Amoxicillin 50 mg/kg/day q 6 hrs for 3-5days, max dose: 500 mg q6 hrs** Note: * Efficacy for prevention of leptospirosis was seen in vitro and animal models

** No clinical trial for prevention of leptospirosis, but amoxicillin is a known alternative for the treatment of disease

Doxycycline has been known to cause permanent discoloration or enamel

hypoplasia in developing teeth (among fetuses and children). There are currently no

good quality evidence on pre- or post-exposure prophylaxis among children and

pregnant patients. However, the American Academy of Pediatrics recently released

a new statement saying that short course doxycycline therapy (i.e. <21 days) is not

expected to cause teeth discoloration in children <8 years.14 As such, the Pediatric

Infectious Disease Society has come up with chemoprophylactic recommendations

for children. For pregnant patients, the use of azithromycin or amoxicillin post-

exposure may be justifiable based on the reasons stated in Table 7 (note).

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XII. REFERENCES

1. Marquez A, Djelouadji Z, Lattard V, Kodjo A. Overview of laboratory methods to diagnose

Leptospirosis and to identify and to type leptospires. Int Microbiol. 2017;20(4):184-193.

doi:10.2436/20.1501.01.302

2. World Health Organization Southeast Asia Regional Office. Leptospirosis - Fact Sheet.

http://www.searo.who.int/about/administration_structure/cds/CDS_leptospirosis-

Fact_Sheet.pdf. Accessed July 4, 2019.

3. Yanagihara Y, Villanueva S, Yoshida S, Okamoto Y, Masuzawa T. Current status of

leptospirosis in Japan and Philippines. Comp Immunol Microbiol Infect Dis. 2007;30:399-413.

4. United Nations Office for the Coordination of Humanitarian Affairs. Philippines Typhoon

Season 2009 Situation Report#14 (30 October 2009).; 2009.

5. Republic of the Philippines Department of Health. Leptospirosis Quarterly Surveillance Report

No. 4 (2018).; 2018.https://portal2.doh.gov.ph/sites/default/files/statistics/

2018_Leptospirosis_QSR_N4.pdf. Accessed July 4, 2019.

6. Roxas EA, Alejandria MM, Mendoza MT, Roman ADE, Leyritana KT, Ginete-Garcia JKB.

Leptospirosis Outbreak after a Heavy Rainfall Typhoon in the Philippines: Clinical Features,

Outcome and Prognostic Factors for Mortality. Acta Med Philipp. 2016;50(3):121-128.

https://www.actamedicaphilippina.org/article/6866-leptospirosis-outbreak-after-a-heavy-

rainfall-typhoon-in-the-philippines-clinical-features-outcome-and-prognostic-factors-for-

mortality. Accessed July 4, 2019.

7. Amilasan A-ST, Ujiie M, Suzuki M, et al. Outbreak of leptospirosis after flood, the Philippines,

2009. Emerg Infect Dis. 2012;18(1):91-94. doi:10.3201/eid1801.101892

8. Collaborative Statement of the Philippine Society for Microbiology and Infectious Diseases,

Philippine Society of Nephrology and the Philippine College of Chest Physicians Council on

Critical Care and Pulmonary Vascular Diseases. The Philippine Clinical Practice Guidelines

on the Diagnosis, Treatment and Prevention of Leptospirosis in Adults 2010. 2010.

9. Brato D, Mendoza M, Cordero C, et al. Validation of the World Health Organization (WHO)

Criteria Using the Microscopic Agglutination Test (MAT) as the Gold Standard in the

Diagnosis of Leptospirosis. PJMID. 27(4):125-128.

10. Brett-Major DM, Coldren R. Antibiotics for leptospirosis. Cochrane Database Syst Rev.

2012;(2):CD008264. doi:10.1002/14651858.CD008264.pub2

11. ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, et al. Acute Respiratory Distress

Syndrome. JAMA. 2012;307(23):2526-2533. doi:10.1001/jama.2012.5669

12. Organized jointly by the American Thoracic Society, the European Respiratory Society, the

European Society of Intensive Care Medicine, and the Société de Réanimation de Langue

Française, and approved by ATS Board of Directors, December 2000. International

Consensus Conferences in Intensive Care Medicine: Noninvasive Positive Pressure

Ventilation in Acute Respiratory Failure. Am J Respir Crit Care Med. 2001;163(1):283-291.

doi:10.1164/ajrccm.163.1.ats1000

13. Pediatric Infectious Disease Society of the Philippines. POST DISASTER INTERIM ADVICE

ON THE PREVENTION OF LEPTOSPIROSIS IN CHILDREN. 2012.

14. American Academy of Pediatrics Committee on Infectious Diseases, Kimberlin D, Brady M,

Jackson M, Long S. Red Book 2018-2021 Report of TheCommittee on Infectious Diseases.

31st ed.; 2018. https://redbook.solutions.aap.org/book.aspx?bookid=2205. Accessed July 4,

2019.

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APPENDICES

Appendix A. Modified Faine’s Criteria (2012)

This check-list is designed for those who deal directly with the patient. It may

be used even before results of leptospiral diagnostic tests are available. To use the

this, give the appropriate score if the parameter is present for the patient and

compute for the sum.

MODIFIED FAINE’S CRITERIA (2012)

Clinical data (Part A)

Epidemiological factors (Part B)

Bacteriological and laboratory findings (Part C)

Headache 2 Rainfall 5 Isolation of leptospira in culture - Diagnosis certain

Fever 2 Contact with contaminated Environment

4 PCR 25

Temperature >39°C 2 Animal contact 1 Serology

Conjunctival suffusion 4 ELISA IgM positive* 15

Meningism 4 SAT positive* 15

Conjunctival suffusion + Meningism + Myalgia

10 Other rapid tests** 15

Jaundice 1 MAT – single positive in high titer

15

Albuminuria/Nitrogen retention 2 MAT – rising titer/seroconversion

25

Hemoptysis/Dyspnea 2 * Any one of the tests only should be scored ** Latex agglutination test/Lepto dipstick/Lepto Tek lateral flow/Lepto Tek Dri-Dot test

Presumptive diagnosis of leptospirosis is made if: Part A or Part A and Part B score: 26 or more Parts A, B, C (Total): 25 or more

A score between 20 and 25 suggests leptospirosis as a possible diagnosis.

Table adapted from: Shiva Kumar, S. Indian Guidelines for the Diagnosis and Management of Human Leptospirosis (2013), p. 26. Accessed on 4 July 2019 from http://www.apiindia.org/medicine_update_2013/chap07.pdf

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Chapter 2: UPSURGE POLICIES AND PROCEDURES

I. STATEMENT OF PURPOSE AND SCOPE

A. Purpose

It is the purpose of this manual to define the actions and roles necessary to

provide a coordinated response during an upsurge in leptospirosis cases in the

HEALTHCARE FACILITY. This manual provides guidance to all the Departments

within the HEALTHCARE FACILITY, with a general concept of potential Upsurge

assignments before, during, and following a Leptospirosis Upsurge. It also

provides for the systematic integration of Upsurge resources when activated

including purchasing of necessary supplies and materials for renal replacement

therapy, supporting the provision of necessary services, and even upgrading the

facilities of the areas assigned to become temporary “leptospirosis wards.”

Important as well is the allocation of financial support or resources from

government agencies such as the Department of Health (DOH), specifically the

Health Emergency Management Bureau (HEMB) and the Field Implementation

and Coordination Team for NCR. It also includes activation of communications

networking with relevant government, non-government agencies and media

focusing on the prophylaxis, prevention and early treatment of leptospirosis.

B. Scope

This plan applies to all participating Divisions/Departments within the

HEALTHCARE FACILITY.

II. KEY POLICIES

A. Criteria for Activation of the Leptospirosis Upsurge Policy

The Leptospirosis Upsurge Policy will be activated when there is a surge in the

number of leptospirosis patients requring admission to the HEALTHCARE

FACILITY to ensure that patients receive appropriate and timely medical care,

renal replacement and respiratory support using the HEALTHCARE FACILITY

criteria to guide health care:

Opening of a Leptospirosis Ward

The HEALTHCARE FACILITY will identify the CRITICAL NUMBER OF

PATIENTS BEING ADMITTED FOR LEPTOSPIROSIS PER DAY that will

activate the policies and procedures in this handbook. When this critical number

of patients who require more than simple hydration (i.e. renal replacement

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therapy, blood component transfusion or requiring respiratory support) is

reached, a Leptospirosis Ward will be identified and opened for these patients.

Stable patients who do not require ventilatory support will be placed in the

Leptospirosis Ward, while toxic patients who are unstable, requiring inotropic

support, ventilatory support or who require intensive monitoring as they are likely

to need intubation, will be admitted to the regular wards. Unstable patients will be

placed in a special identified ward with a higher nurse to patient ratio.

B. Person Responsible for Activation of the Leptospirosis Upsurge Policy

DURING OFFICE HOURS from Monday-Friday, 8:00AM - 5:00PM, the

Head Nurse and Head Consultant of the Emergency Room (ER) will inform the

Executive Office if the criteria for activation of the Leptospirosis Upsurge Policy

has been met. Any one of the Deputy Executive Directors or the Chief of Hospital

will activate the Leptospirosis Upsurge Policy.

Upon Activation of the Leptospirosis Upsurge Policy, the Secretary of any of

the Deputy Executive Directors or Chief of Hospital will send out a memorandum

through Outlook, and will notify the Heads of the following Departments /

Divisions:

Divisions of Adult and Pediatric Nephrology

Division of Internal Medicine

Division of Organ Transplantation and Vascular Surgery

Nursing Services

- All Head Nurses or Charge Nurses in all Clinical Wards

- Operating Room (OR)

Department of Pathology and Laboratory Medicine

Section of Pulmonary Medicine

Pharmacy, Procurement, Supply, Central Supply and Sterilization Unit

(CSSU), Housekeeping, Billing and Claims, Admitting and Discharge

Medical Social Services Division (MSSD)

Information Resource Management Division (IRM)

- Upload Hospital Memorandum regarding the activation of the

Leptospirosis Upsurge Policy to all concerned departments through

OUTLOOK

- Inform all Heads of the concerned Department/Division including the

Chief of Hospital and Deputy Executive Directors through SMS

HEALTHCARE FACILITY-HEMB

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AFTER OFFICE HOURS from Monday-Friday, weekends and holidays, the

ER Charge Nurse will contact the Senior House Officer (SHO) who will activate

the Leptospirosis Upsurge Policy and inform IRM to disseminate the information.

(See Diagram I)

Diagram I: Activation of Leptospirosis Upsurge Policy

after Office Hours

C. Activation of the Leptospirosis Upsurge Management Team

Once the Leptospirosis Upsurge Policy is activated, the Chief of Hospital or

any of the Deputy Executive Directors will call on a meeting of the Leptospirosis

Upsurge Management Team, to coordinate efforts on ensuring adequate

provisions of necessary services for the leptospirosis patients. Meetings can be

called on daily to update the entire team of the needs of the Leptospirosis ward

and other areas. A Leptospirosis Upsurge Management Team Head will be

assigned by the Chief of Hospital.

This team is composed of the following:

Chief of Hospital/Deputy Executive Director/s – Head

Chair, Departments/Divisions of Adult and Pediatric Nephrology, Internal

Medicine, Vascular, Laboratory Medicine

Deputy Executive Director for Nursing Services

ER Head

Head Nurse of ER, Clinical Wards, HD Unit, PD Unit, Operating Room

Head of Housekeeping, Purchasing, Warehouse, Pharmacy, CSSU,

PBSD, MSSD, IRM, HEALTHCARE FACILITY-HEMB

ER

Chief of Hospital and Deputy Executive Directors

Senior House Officers (SHO)

All Other Departments

All Medical Depts/Divisions

Nursing IRM

Deploy Memo through OUTLOOK to all those on Duty and all the their Heads by SMS

All Nursing Departments

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D. Critical Bed Status Procedure – HEALTHCARE FACILITY Leptospirosis Upsurge

Policy

It is the goal of this Policy to provide a systematic method for identifying the

available hospital beds, to unload the ER, to ensure that beds are being

appropriately used during critical bed status, and to prevent the denial of

transfers from other government hospitals during a Leptospirosis Upsurge. This is

to ensure that patients receive proper medical care.

Procedure:

The post duty Senior Adult Nephrology Fellow will report on the total bed

status and availability, to the Head of the Leptospirosis Upsurge Management

Team by 8:00AM every morning.

The Chief Fellow / Resident will prioritize admissions of the Leptospirosis

patients especially those who need RRT or require ventilator support.

E. Standards for Admission of Leptospirosis Patients

All patients with a presumptive diagnosis of Leptospirosis will be triaged

under the Division of Internal Medicine with the following criteria:

1. Serum Creatinine: < 3 mg/ dl

2. Absence of Criteria for Pulse Therapy

All patients with a presumptive diagnosis of Leptospirosis will be triaged

under the Division of Adult Nephrology (Patients > 19 yo) or Pediatric

Nephrology (Patients < 18 yo and 364 days) with the following criteria:

1. Serum Creatinine: > 3 mg/ dl

2. Presence of any ONE of the Criteria for Pulse Therapy (See Appendix A)

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III. ROLES AND RESPONSIBILITIES OF THE VARIOUS DEPARTMENTS /

DIVISIONS / SECTIONS IN THE MANAGEMENT OF A LEPTOSPIROSIS

UPSURGE

A. Emergency Room (ER)

Provide emergency medical treatment, triage patients and ensure

administrative or clinical backup for the ER.

Stamp clinical charts with “LEPTOSPIROSIS” so that the Pharmacy, CSSU

and other concerned areas will be alerted that the requests should be

provided, without pre-approval by MSSD.

Refer patients who fulfill the criteria for Leptospirosis immediately to

Nephrology or Internal Medicine. Patients developing acute kidney injury, who

fulfill the criteria for renal replacement will be treated without delay. This

should be provided to all patients and will not require MSSD pre-approval.

The Head of the ER should ensure that the Leptospirosis Prophylaxis Survey

2013 is completed for all patients and placed in the clinical chart of the patient.

The Chief Fellow of the Division of Adult Nephrology should collect the survey

forms including forms from Pediatric Nephrology and Internal Medicine. (See

Appendix B)

The Head Nurse of the ER shall ensure that the ER Procedure Room is

adequately prepared for use and will maintain adequate sterility for dialysis

access procedures. The appropriate measures to maintain sterility of the area

especially between procedures will be applied.

ER Nephrology fellows shall refer patients requiring access placement for

either hemodialysis (HD) or peritoneal dialysis (PD) to the Department of

Vascular Surgery / General Surgery. Placement of a temporary HD catheter

will be done either in the ER Procedure Room or Operating Room (OR) to

ensure that there is no delay in dialysis access placement. Placement of HD

access may also be performed by the Nephrology Fellow as per Division of

Adult Nephrology protocol. Placement of a temporary PD catheter will be done

in the OR only.

The Head Nurse of the ER shall ensure that there are enough supplies for

either HD or PD access placement, sufficient number of cut-down sets and

other supplies necessary at the ER. These should be provided to all patients

and will not require MSSD pre-approval. Any problems with supplies should be

communicated immediately to the Head of the Leptospirosis Upsurge

Management Team, Head of Warehouse, CSSU, and Purchasing.

- For HD access – use triple lumen catheters

- For intubation – use ET tube with subglottic suction

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Residents and fellows shall refer patients to MSSD for completion of clinical

information for inclusion as a service patient, and for possible application for

the PhilHealth Leptospirosis benefit or other funding agencies to assist the

HEALTHCARE FACILITY in sourcing funds for these patients.

Residents and fellows shall refer patients who will require admission to the

clinical wards (for patients on inotropes, require ventilator support, or who are

clinically unstable) to the appropriate Medical Department/Division for

facilitation of admission, while all other patients will be admitted to the

Leptospirosis Ward.

B. Division of Internal Medicine

Assess patients and ensure that they are given adequate hydration,

appropriate antibiotics and that patients are monitored. The Division is also

responsible for following the Leptospirosis algorithm for proper diagnosis,

management and documentation. The ER Medical Residents on duty are in

charge of providing an efficient patient flow, consultation, and disposition at the

ER.

◊ Patients will be admitted to the appropriate pay or service beds as necessary.

The total daily number of patients admitted under the IM Service will be

reported to the post duty Senior Adult Nephrology Fellow who will be

responsible for consolidating the DAILY CENSUS of patients with

Leptospirosis.

Medical service residents will manage, monitor and provide proper medical

disposition of patients admitted under IM service. If necessary, the service

resident will transfer patients to nephrology service once the patient requires

intravenous methylprednisolone pulse therapy and renal replacement therapy.

Subspecialty service rotators will work in conjunction with nephrology fellows

to manage difficult and complicated Leptospirosis cases. Rotators are also

responsible for referring cases to the subspecialty consultant of the month.

Medical service residents assigned to the Leptospirosis Ward will be

responsible for answering urgent calls for patients admitted under IM service

in the Leptospirosis Ward, in the absence of a nephrology fellow, and promptly

refer to the service consultant.

Medical Staffing of the Leptospirosis Ward is seen in Section V.

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C. Divisions of Adult and Pediatric Nephrology

Assess patients, provide renal replacement therapy / hydration as needed,

and ensure that appropriate medications are administered. Nephrology fellows

prioritize admissions based on the medical needs of patients. The NKTI is the

tertiary referral center for renal disease for all DOH hospitals and will accept

referrals from these hospitals for renal replacement. DOH hospitals with RRT

services referring patients to NKTI will be reported to the Head of the

Leptospirosis Upsurge Management Team and to DOH.

Patients who fulfill the criteria for renal replacement will be allocated to either

HD or PD according to the algorithm in Appendix A and C.

Since the patients are diagnosed with acute kidney injury, this illness is

reversible and all the needs for dialytic therapy, antibiotics and other

therapeutics will be provided.

The Division of Adult Nephrology will serve as the lead Department in

consolidating the census for all patients seen at the ER and admitted,

including basic demographics, treatment and outcome. (See Appendix D)

The post duty Senior Adult Nephrology Fellow will be responsible for

consolidating the 24-hour daily census of patients with Leptospirosis from all

Departments at 12:00AM using the appropriate form (See Appendix D). This

will be emailed to the Chief of Hospital, the Head of the Leptospirosis Upsurge

Management Team, the Chair of the Division of Adult Nephrology, and to the

Epidemiology Bureau and HEMB Operations Center, under the Department of

Health.

The PD Fellow 1 will be in charge of the Leptospirosis Ward and all the other

Leptospirosis patients during office hours. After office hours, the PD Fellow 2

will take over and endorse the patients back to PD Fellow 1 in the morning.

Nephrology Staffing of the Leptospirosis Ward is seen in Section V.

The Head of the Leptospirosis Upsurge Management Team will coordinate

with any of the concerned Departments/Divisions/Sections of HEALTHCARE

FACILITY, as needed, to ensure that patients are treated in a timely manner,

and to ensure that all the patients' needs are provided. The Head of the

Leptospirosis Upsurge Management Team will update the Chief of Hospital /

Deputy Executive Directors as necessary.

The Head of the Leptospirosis Upsurge Management Team and/or the Chief

of Hospital / Deputy Executive Directors, will attend the DOH-HEMB meetings,

as necessary, to provide updates on the status of patients admitted at the

HEALTHCARE FACILITY and to request for logistical support, if necessary.

Nephrology Staffing of the Leptospirosis Ward is seen in Section V.

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D. HEALTHCARE FACILITY-Health Emergency Management Bureau (HEMB)

Team

The HEALTHCARE FACILITY-HEMB Team will be included in the

Leptospirosis Management Team. They will facilitate requests for augmentation

of staffing and resources as necessary from the DOH-HEMB Office or the Field

Implementation Coordination Team DOH-NCR. They will coordinate with the

Head of the Leptospirosis Upsurge Management Team for any other needs.

E. Division of Organ Transplantation and Vascular Surgery

Responsible in providing timely insertion of temporary HD catheters or PD

catheters and their removal, prior to patient’s final discharge and other surgical

procedures if deemed necessary.

F. Department of Pathology and Laboratory Medicine

Responsible for processing of blood chemistry, hematology, transfusion

requirements, microbiology, coagulation, and urinalysis available 24/7 for

patients with Leptospirosis.

Responsible for storage of blood for MAT, and to find out where these tests

can be done at the lowest possible price. Shall ensure that the required clinical

information is completed for the MAT tests.

G. Section of Pulmonary Medicine

Responsible for pulse oximetry, nebulization, arterial blood gas, and providing

mechanical ventilatory support in a timely manner.

The ECMO TEAM, headed by a Pulmonary consultant will decide whether or

not referred leptospirosis patients fulfill the criteria for ECMO therapy. Once a

patient is identified then the ECMO Team Head will activate the

HEALTHCARE FACILITY multi-disciplinary ECMO Team to provide the

necessary services for the patient. The ECMO Team head ensures the

availability of ECMO supplies such as oxygenator, cannulaes and various

tubings.

Medical criteria for assisted ventilation and ECMO therapy is seen in

Appendix E.

H. Department of Medical Imaging and Therapeutic Radiology

All radiologic services should be readily available to the ER, Leptospirosis and

medical wards for all diagnostic studies and services utilizing the portable x-

ray machine, ultrasound or CT scan as necessary.

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I. Nursing Services

Assures that there is adequate nursing staffing complement, equipment,

medications and supplies, and that proper nursing care is provided.

In preparation for the activation of the Leptospirosis Upsurge Policy a 1-week

learning and development intervention on HD will be facilitated and scheduled

at least once a year or as necessary. A similar workshop for PD will be

facilitated at least once a year or as necessary to ensure that there are

sufficient nurses in the ward adept at PD. This comprises 8-hours of a lecture

workshop program and 40 hours of practicum.

Senior staff nurses will be identified from each ward to undergo the HD and/or

PD training as above. These nurses will be assigned to the Leptospirosis

Ward once opened, and new staff nurses will be assigned to replace them in

their respective units.

Nurse Staffing of the Leptospirosis Ward is seen in Section V.

J. Hemodialysis (HD) Unit

The HD Unit Head will determine whether HD machines will be placed in the

Leptospirosis Ward to facilitate HD treatments, so as not to disrupt the in-

patients and ER patients requiring urgent HD. The guideline is when there are

at least 16 patients requiring HD from the Leptospirosis Ward, 4-HD machine

stations will be set-up in the Ward with portable reverse osmosis machines.

Once a decision is made to set-up an HD Unit in the Leptospirosis Ward, the

HD Unit Supervisor will contact the HEALTHCARE FACILITY’s HD provider to

augment the number of HD machines and portable RO machines to be placed

in the Leptospirosis Ward, and contact the Provider’s Facility. Engineer and

Biomedical Engineer on duty to assess the area for setting up an HD Unit,

such as the water and power source.

The HD Unit Supervisor or Assistant will coordinate with all the wards where

there are Leptospirosis patients to determine how many patients need HD and

to schedule their treatments according to the prioritization level given by the

Division of Adult Nephrology, and where the patients will have their HD

treatments, ie. in the Leptospirosis Ward or in the HD Main Unit.

If an HD Unit will be set-up in the Leptospirosis Ward, the following will be put

in place:

- 1 Computer Station

- 1 Telephone Line

- Sufficient HD supplies and on and off dressing kits

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The HD Charge Nurse and HD technicians will prepare and set-up the HD

Unit. The HD Unit Supervisor or Assistant will arrange for additional HD staff if

necessary, to ensure that the provision of HD is not disrupted.

An HD fellow should be present at all times when there are patients

undergoing HD in the Leptospirosis Ward.

All prescriptions for medications, supplies, dialysis orders and laboratories

shall be stamped with “LEPTOSPIROSIS” so that the Pharmacy and CSSU

will be alerted that the requests should be provided, without pre-approval by

MSSD.

K. Peritoneal Dialysis (PD) Unit

Once the Leptospirosis Upsurge Policy is activated, the PD Unit Supervisor

will contact the HEALTHCARE FACILITY’s PD Provider to augment the

number of PD cycler machines as needed, to accommodate the increased

number of patients who will be requiring PD and to request for additional PD

Nurses to assist the PD Unit in providing PD services.

The PD Unit Supervisor will ensure that there are sufficient supplies of PD

catheters, solutions and accessories at all times, in coordination with

Warehouse and Purchasing in all areas where Leptospirosis patients are

admitted, especially in the Leptospirosis Ward.

The PD Nurses will monitor all Leptospirosis patients who are started on PD

therapy, whether manual or cycler-assisted.

Patients will not be allowed to do their own PD exchanges while admitted in

the wards.

The PD nurses will ensure that PD is performed in a sterile manner and that

there is no PD-related infection.

The PD nurses will ensure that PD is done as prescribed, according to the

prescription of the Nephrologist.

The PD Nursing Attendant will assist the PD nurses in all activities related to

PD.

Once the patient is ordered discharged by Nephrology, the PD Nurse will

ensure that the patient is referred back to Vascular Surgery for removal of the

PD catheter prior to discharge. This should be performed in the OR. The PD

Nurse will ensure that the appropriate charges for PD catheter removal are

made.

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L. Infection Prevention and Control Committee

Tasked to monitor cases of Leptospirosis and to submit the cases to the DOH-

Philippine Integrated Disease Surveillance and Response through master

database system.

The post duty Senior Adult Nephrology fellow will email to the IPCC Office the

daily leptospirosis tally and census.

M. Medical Social Services Division (MSSD)

Facilitate care regarding the psychological and social needs of patients.

The MSSD will provide staff that will be available 24 hours a day, 7 days a

week with on-call coverage at all times during activation of the Leptospirosis

Upsurge Policy.

They are responsible for determining if patients are already members of

PhilHealth, or are dependents of PhilHealth members, and if not, for

completing all the information necessary for patients to enroll in PhilHealth at

point-of-care.

They will complete a database on all patients treated, demographics, the type

of dialysis provided, if any, and outcome, dates of admission and discharge,

referring hospital, financial assistance, PHIC membership and running

charges.

Since patients may develop reversible acute kidney or liver injury, all the

medical needs should be provided without the need for pre-approval from

MSSD.

They will prepare the running balance of expenses related to Leptospirosis

and submit regular reports to the Chief of Hospital and to the Head of the

Leptospirosis Upsurge Management Team and other Executives.

N. Pharmacy Division

Responsible for making sure that patients receive the most appropriate

medicines in the most effective and timely way. They prepare and dispense

medications.

All the Pharmacy requirements should be provided without the need for pre-

approval from MSSD.

They will ensure that the Leptospirosis Ward and other wards that have

admitted Leptospirosis patients are provided with all the necessary

medications (See Appendix A and C) such as:

- Amoxicillin suspension 250mg/5ml

- IV Penicillin G 1.5M units/vial

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- IV Ceftriaxone 1 gram/vial

- IV Hydrocortisone 100mg/ampule

- IV Methylprednisolone 500mg/vial

- IV Cyclophosphamide 1gram/vial

- IV Potassium chloride 2meq/ml, 5ml/vial

- IV Calcium gluconate 10%/vial

- IV Magnesium sulfate 50%/vial

The following should also be available in sufficient quantities:

- Doxycycline 200mg/cap

- Amoxicillin 500mg/cap

- Omeprazole 40mg/amp

- IV Plain NSS 1liter/ bottle

- Dopamine 200mg/5ml vial

- Norepinephrine 1mg/ml, 10ml vial

- Dobutamine 250mg/25ml vial

O. Housekeeping Section

Tasked to set up the Leptospirosis Ward once ordered by the Head of the

Leptospirosis Upsurge Management Team for a maximum of 50-cot beds.

(See Part IV)

P. Procurement and Supply Management Divisions

Strategize, lead and manage logistics to ensure operational effectiveness. It

includes ensuring the hospital has sufficient inventory to manage the

Leptospirosis Upsurge, and that all inventory are accurately accounted for at

all times.

They will manage and direct the timely and cost effective supply of goods.

All purchases in relation to the treatment of Leptospirosis patients or in

augmenting supplies or equipment for the Leptospirosis Ward shall be

reported on a weekly basis and submitted to the Head of the Leptospirosis

Upsurge Management Team, the Chief of Hospital and to the Deputy

Executive Director for Hospital Support Services.

The Head of Procurement and Supply Management Divisions must inform the

Head of the Leptospirosis Upsurge Management Team immediately if there

are problems with stocks required to support the services for the Leptospirosis

Ward.

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Q. Central Supply and Sterilization Unit (CSSU)

Responsible for supplying all of the wards of the hospital with all of the

supplies necessary to complete daily operations.

They are in charge of keeping the hospital's storage facilities stocked with

adequate supplies for HD, PD, dialysis access, cut down sets etc.

The following should be available in sufficient supply:

- Paper tape

- Hand sanitizer

- Cotton balls

- Povidone-iodine

- Alcohol

- Foley catheters

- Cut down set

- Endotracheal tube standard

- Endotracheal Tube with subglottic

suction

- Nasogastric tube

- HD triple lumen catheters for right

and left internal jugular vein

- PD catheters (Adult and Pediatric)

R. Billing and Claims Division

They are responsible for the preparation of hospital bills for Leptospirosis

patients.

They are responsible for submitting claims to PhilHealth for point-of-care

benefit, as well as the routine claims for PhilHealth members.

They will provide reports to Management on a weekly basis on the total

subsidy by the HEALTHCARE FACILITY for Leptospirosis patients in

coordination with MSSD.

They will coordinate with IRM to ensure that patients are charged with the

appropriate room rates when they are admitted to the Leptospirosis Ward.

S. Admitting and Discharge Section

They will facilitate admission of patients with Leptospirosis to the designated

Leptospirosis Ward or service beds, and ensure that the appropriate room

rates are charged for service patients.

The Admitting “face sheet” shall be stamped with “LEPTOSPIROSIS” so that

the Wards, Pharmacy, CSSU and other concerned areas will be alerted that

the medical diagnostics and treatments should be provided, without pre-

approval by MSSD.

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T. Information Resource Management Division (IRM)

Responsible for the management of data within HEALTHCARE FACILITY, to

ensure a seamless coordination with the different Departments.

They will set-up the computer stations in the Leptospirosis Ward Nurses

Station with connectivity to the Medsys and radiology system and for the HD

unit set-up in the Leptospirosis Ward.

They will ensure that charges for use of the ER-OR for removal of either HD or

PD catheters are included in the patient's final hospital bill, even if the patient

is admitted in the wards.

U. Nutrition and Dietetics Division (NDD)

They will provide meals for all patients in the Leptospirosis Ward.

They will provide meals for the HEALTHCARE FACILITY staff and augmented

staff from other hospitals assigned to the Leptospirosis Ward.

Once there are more than 100 patients admitted for Leptospirosis, in excess of

the total number of in-patient beds, they will do emergency purchase of food

items and other supplies to ensure the continuous supply of meals.

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IV. SETTING UP A LEPTOSPIROSIS WARD

Once the Leptospirosis Ward is opened, the following should be put in

place for a 30 to 50 bed ward by the Housekeeping Unit:

Patient cots

IV stands

1 watcher chair per patient

Bed linens

BP Apparatus

Wheel chairs with IV stand

Oxygen gauge

Oxygen tank

Oxygen mask

1 Disposable thermometer per patient

Infusion pumps

The following may be placed in the Leptospirosis Ward if needed:

Extension wires for the infusion pumps, coolers, PD cyclers, HD machines

etc.

Air Coolers or industrial fans

Freezers or ice chests

Water dispenser

A Nurses Station will be put in place in a strategic area in the Leptospirosis

Ward to ensure accessibility to communications. The Nurses Station will be

equipped with the following:

3 Computer stations with access to charging of supplies etc., access to the

HEALTHCARE FACILITY COMMUNICATIONS MODULE for laboratories

etc. and 1 printer

2 Telephone units

Forms: laboratory requests, admitting forms, order sheets, TPR sheet,

input/output sheet etc.

Patient folders or clipboards

Basic medical supplies for patients

HD access catheters, PD catheters and supplies

Dressing kits and cut-down sets

Other logistics such as industrial electric fans, ice for the fans etc. may be

requested from the Housekeeping Section

The PD Unit will be informed for transfer of PD cycler machines as needed.

All prescriptions for medications, supplies, dialysis orders and laboratories shall

be stamped with “LEPTOSPIROSIS” so that the Pharmacy and CSSU will be

alerted that the requests should be provided, without pre-approval by MSSD.

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V. STAFFING REQUIREMENTS IN THE LEPTOSPIROSIS WARD

A. Medical Staffing in the Leptospirosis Ward

The goal for medical staffing is to maintain a doctor-patient ratio of 1:20. The

Adult Nephrology PD fellow 1 is assigned to cover the Leptospirosis Ward until

a maximum of 20 patients. The PD fellow 2 goes on night duty at the

Leptospirosis Ward.

Pediatric Nephrology fellows make rounds on their patients only, but do not go

on duty at the Leptospirosis Ward. Once there are more than 10 pediatric

patients at the Leptospirosis Ward then a Pediatric Nephrology fellow will go

on duty in the area.

One Internal Medicine resident is also assigned to the Leptospirosis Ward

once it opens.

Once there are >20 to 40 patients, the PD senior and GN senior fellows are

called to augment staffing on rotation to maintain at least 2 Nephrology fellows

at any time. At this point, fellows from outside rotations and elective rotations

will be recalled to assist in going on duty in the Leptospirosis Ward.

A Nephrology fellow must be at the Leptospirosis Ward while there are

patients undergoing HD in the area.

Seriously ill patients are admitted to the regular hospital wards (ie. require

inotropes, active bleeding, require oxygen support). Thus, relatively stable

patients, dialysis-dependent, hydration requiring alone, are confined in the

Leptospirosis Ward.

Once the Leptospirosis Ward reaches a capacity of 40 patients or more, the

Senior Nephrology Fellow will inform the Head of the Leptospirosis Upsurge

Management Team and the Chief of Hospital to request for external staff

augmentation from other Institutions to help in monitoring of patients. The

HEALTHCARE FACILITY Chief of Hospital will inform the DOH-Field

Implementation and Coordination Team-NCR, of the need for medical staff

augmentation. Physicians with experience in attending to general medical

patients will be preferred. They will report to the Chief Adult Nephrology Fellow

for assignment.

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B. Nurses Staffing in the Leptospirosis Ward

Once the HEALTHCARE FACILITY has 30 patients admitted, they will be

placed in the identified “Leptospirosis Ward” and the Leptospirosis Critical

Extension Ward (for Patient Classification System (PCS) Level IV).

12 nurses, 6 nursing attendants and 1 clerk from the different units of

HEALTHCARE FACILITY will be identified and pulled-out and assigned to the

Leptospirosis Ward. Three nurses and 1 nursing attendant will be assigned

per shift with the nurse-patient ratio of 1:8-10.

For leptospirosis patients on PD, a PD Unit Roving nurse will do the rounds on

a regular basis to facilitate PD.

Once the number of patients exceeds 30, the Deputy Executive Director for

Nursing Services will inform the Head of the Leptospirosis Upsurge

Management Team and the Chief of Hospital to request for external staff

augmentation from other Institutions to help in monitoring of patients. The

Head of the Leptospirosis Upsurge Management Team and/or Chief of

Hospital will inform DOH-Field Implementation and Coordination Team-NCR,

of the need for staff augmentation (physicians, nurses, nursing attendants etc.)

The Assistant Coordinator of the Health Emergency Management Bureau

(HEMB) of HEALTHCARE FACILITY will likewise be informed of the need for

staff augmentation to coordinate with HEMB.

Nurses staffing augmentation will be composed of 12 nurses and 6 nursing

attendants to be assigned to either of the two identified units or to the ER.

They will report to the Deputy Executive Director for Nursing Services or

his/her representative for the assigned area of deployment.

The Chief of Hospital and other Deputy Executive Directors may also call other

Department of Health Hospitals, Army Hospitals or LGU Hospitals for

assistance in augmenting the staffing needs.

Once the number of leptospirosis cases decreases to thirty (30) and below,

the augmentation team shall return to their respective hospitals.

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VI. HEALTH CARE PROVIDER NETWORK (previously called as SDN)

To guarantee access of patient with Leptospirosis to quality and affordable health

services, without causing any financial burden it is important that a Health Care

Provider Network be established.

Under the Universal Health Care Law, RA 11223, Sec. 4.i. Health Care Provider

Network refers to a group of primary to tertiary care providers, whether public or

private, offering people-centered and comprehensive care in an integrated and

coordinated manner with the primary care provider acting as the navigator and

coordinator of health care within the network.

An important key feature of a Health Care Provider Network is a functional Two-way

Referral System which will help ensure the continuity of care from one health service

facility to another. It Includes:

1. Transport system to move the patient from one facility to another

2. Establishment of two-way communication system

3. Interoperable information system

4. Clearly defined referral manual

The NKTI is one of four specialty hospitals strategically situated in Metro Manila. As

an end referral hospital for patients suffering from severe form of Leptospirosis with

pulmonary and/or renal complication, maximization of its service capability utilization

for targeted patient population can be achieved efficiently thru a functional service

provider network currently being organized by DOH-FICT Team (NCR and MM).

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VII. ANTIBIOTIC PROPHYLAXIS FOR LEPTOSPIROSIS

For relatives of patients and HEALTHCARE FACILITY employees with a

history of flooding in flooded waters, the following prophylaxis should be given:

A. Recommended post-exposure prophylaxis for Leptospirosis for adults

(San Lazaro Hospital’s Guideline on Prophylaxis for Leptospirosis 2009)

LOW-RISK EXPOSURE is defined as those individuals with a single history of

wading in flood or contaminated water without wounds, cuts or open

lesions of the skin.

Doxycycline 200 mg single dose within 24 to 72 hours from exposure

[Grade B]

MODERATE-RISK EXPOSURE is defined as those individuals with a single

history of wading in flood or contaminated water and the presence of wounds,

cuts, or open lesions of the skin, OR accidental ingestion of contaminated

water.

Doxycycline 200 mg once daily for 3-5 days to be started immediately

within 24 to 72 hours from exposure [Grade C]

HIGH-RISK EXPOSURE is defined as those individuals with continuous

exposure (those having more than a single exposure or several days such as

those residing in flooded areas, rescuers and relief workers) of wading in flood

or contaminated water with or without wounds, cuts or open lesions of the

skin. Swimming in flooded waters especially in urban areas infested with

domestic/ sewer rats and ingestion of contaminated water are also considered

high risk exposures.

Doxycycline 200 mg once weekly until the end of exposure [Grade B]

B. Recommended post-exposure prophylaxis for Leptospirosis for pregnant

women

Amoxicillin 500 mg/tab 1 tab BID x 3 days

If allergic to amoxicillin, may give erythromycin 250 mg BID x 3 days

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C. Recommended post-exposure prophylaxis for Leptospirosis for children

From the Post Disaster Interim Advice on the Prevention of Leptospirosis in

Children. August 10, 2012. Pediatric Infectious Disease Society of the

Philippines, Inc.

Drug Dose Comments

Doxycycline 4mg/kg single

dose,

Max: 200mg

Proven efficacy for preventing clinical

disease.

Adverse effects are similar to other

tetracyclines; in children below 8 years of

age, doxycycline is unlikely to cause

dental staining at the dose and duration

recommended to treat serious infections.

Avoid milk, dairy products, iron and

antacids 1 hour before and 2 hours after

administration; may be given with food to

avoid stomach upset.

Alternative

Drugs

Azithromycin

Efficacy for prevention of leptospirosis

was seen in vitro and animal models.

Amoxicillin 50mg/kg/day

divided into 4

doses for 3-5

days

Max: 500mg

q6H

No clinical trial for prevention of

leptospirosis, but amoxicillin is known

alternative for the treatment of disease.

Dose is for 3-5 days due to the very short

half-life.

If children are exposed for more than 7 days, the dose should be repeated

after 1 week.

*This algorithm for Leptospirosis was made by the NKTI-Department of Pediatric Nephrology:

Dr. Zenaida Antonio Dr. Ofelia De Leon

Dr. Ma. Angeles Marbella Dr. Ma. Lorna Lourdes Simangan

Dr. Violeta Valderama Dr. Norma Zamora

Dr. Coe Dela Seña

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APPENDICES

Appendix A. Algorithm for Leptospirosis (Revised August 2013)

DIAGNOSTICS: 1. CBC with platelet count 2. Creatinine, Sodium, Potassium Calcium,

Albumin, Lipase 3. ABG as needed 4. Baseline ECG 5. Chest PA 6. PT, PTT Daily if needed 7. LAT IgG and IgM 8. If negative for both, send serum for IgM and

IgG after 7 days 9. Send out specimen for Microscopic

Agglutination Test (MAT) care of Laboratory Medicine Department

INITIAL MANAGEMENT: 1. Fast drip 2 liters Plain NSS

(May insert 2 IV Lines) then continue hydration at 300 cc/ hour

2. Start Penicillin-G at 1.5million units IV every 6 hrs OR Ceftriaxone 1gram IV OD, if patient fulfills criteria for Pulse Therapy.*

*CRITERIA FOR PULSE THERAPY (any one) 1. Platelet count less than 100,000 2. SBP less than 90mm Hg after isotonic fluid resuscitation of 2L 3. Requires inotropes 4. Lung infiltrates on Chest Xray 5. Prolonged PT, PTT

YES NO

Fever, Conjunctival Suffusion, Muscle Aches History of Wading In Flood Waters

+/- Icterisia, Jaundice

Give Methylprednisolone 500 mg/ IV after HD OD x 3 days.

After the 3rd Methylprednisolone dose or after any episode of hemoptysis, give Cyclophosphamide 1 gm IV as a single dose after HD

Give Ceftriaxone 1 gm IV OD (instead of Penicillin G)

Give Omeprazole 40 mg IV OD *If the patient has been started on Hydrocortisone IV, give the remaining steroid dose to reach the target dose of MPP 500 mg/ day (see steroid conversion). Then give the Methyprednisolone 500 mg IV OD on days 2 and 3. *Steroid conversion: Hydrocortisone 5mg = Methyprednisolone 1mg

Patient requires dialysis**

Platelet count >100,000 but less than 150,000

Give hydrocortisone 100 mg IV every 6 hours

Continue IV Penicillin G

Give Omeprazole 40 mg IV OD

YES NO

PROCEED TO ALGORITHM FOR DIALYSIS THERAPY

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* This algorithm for Leptospirosis was made by NKTI Multi-Disciplinary Team composed of:

Dr. Romina Danguilan, Department of Adult Nephrology

Dr. Myrna Mendoza, Internal Medicine, Section of Infectious Disease

Dr. Ernesto Que, Internal Medicine, Section of Gastroenterology

Dr. Joselito Chavez, Internal Medicine, Section of Pulmonary Medicine

ALGORITHM FOR DIALYSIS THERAPY

Urine output: <500cc/day AND/OR Creatinine: >3 mg/dl

YES NO

Continue hydration Do serial laboratory monitoring

FULFILLS ANY OF THE CRITERIA FOR PULSE THERAPY

YES NO

Do acute PERITONEAL DIALYSIS (APD)

1. APD 1.5%, 1.5L per exchange, dwell time 30 min x 40 exchanges.

May use hypertonic exchange if patient needs fluid removal.

2. Hydrocortisone 100mg IV q6 hrs x 3 days

3. Omeprazole 40 mg 1 tab OD

Do Acute HEMODIALYSIS

If with improving creatinine, urine output and better well-being, step down antibiotic to Doxycycline 100mg BID on day 1,

then 100mg OD thereafter OR Amoxicillin 500mg QID, to complete 7 days.

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Appendix B. Leptospirosis Prophylaxis Survey

For Patient

Name: Date of Admission:

Address:

Age/Sex: Chief Complaint:

Exposure to Flood: Yes No Date of Exposure:

Duration in Days: Number of Times Exposed:

Wounds on Exposed Area to the Flood: Yes No

Ingestion of Flood Water: Yes No Prophylaxis Taken: Yes No

Drugs Used and Dosage: Doxycycline 100mg 2x/day for days

Amoxicillin 500mg 2x/day for days

Initial Sign/Symptom:

Signs and Symptoms Began:

Total number of household members including patient:

How many were EXPOSED to flood?

Fill-in for Each Household Member EXPOSED

Type of Household Member:

Family (state relation to patient):

Non-family (state role in household):

Name:

Age/Sex: Date of Exposure:

Duration in Days: Number of Times Exposed:

Wounds on Exposed Area to the Flood: Yes No

Ingestion of Flood Water: Yes No

Prophylaxis Taken: Yes No

If Yes, Drugs Used and Dosage:

Doxycycline 100mg 2x/day for days

Amoxicillin 500mg 2x/day for days

Sign and Symptom:

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Appendix C. Algorithm for Leptospirosis (Pediatric Patients)

SUSPECTED LEPTOSPIROSIS

Fever for 2 days plus

History of wading in flood water plus Nonspecific signs and symptoms

(conjunctival suffusion, headache, myalgia, vomiting, diarrhea, abdominal pain, difficulty of breathing)

+ jaundice/icterisia

YES

DIAGNOSTICS

CBC;

BUN creatinine, serum Na, K, Ca, SGPT Urinalysis Chest xray

Leptospirosis LAT/MAT PT PTT ABGs

MAY SEND PATIENT HOME

For children >8 years old, DOXYCYCLINE 100 mg PO BID on

Day1 then 100 mg OD thereafter or 4mg/kg divided into 2 doses for less

than 50kg

For children 8 years old or less, Amoxicillin 30-50mg/kg/day q6

(max 500mg QID) or

Azithromycin 1g initial dose then

500mg OD or 10mg/kg/day OD for 3 days

ADMIT

NO

Give methylprednisolone 500mg IV after HD OD x 3 days Give ceftriaxone 1g IV OD (instead of Penicillin G) Give omeprazole 40mg IV OD

Low eGFR, high BUN, UO > 0.5cc/kh/hr

stable vital signs (1)

Low eGFR, high BUN,

UO > 0.5cc/kg/hr stable vital signs (2)

Close follow-up Give fluids based in fluid status

MODERATE-SEVERE LEPTOSPIROSIS (AKI-Injury and Failure)

Elevated serum creatinine, with or without hepatic involvement Urine output < 0.5cc/kg/hr with pulmonary congestion/

hemorrhage/ sepsis able to take oral medications

CRITERIA FOR PULSE THERAPY

Any one 1. Platelet count <100,000 2. SBP < 90mm Hg after isotonic

fluid resuscitation of 2L 3. Requires inotropes 4. Lung infiltrates on chest xray 5. Prolonged PT, PTT

MILD LEPTOSPIROSIS (AKI-Risk)

Stable vital signs, no jaundice Urine output > 0.5cc/kg/hr Normal serum creatinine

No evidence of pulmonary congestion/ hemorrhage/ sepsis

able to take oral medications

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(1) (Pediatric Patients)

(2) (Pediatric Patients)

Decreased eGFR, increased BUN, UO increase 0.5cc/kh/hr

stable vital signs

HYPOVOLEMIA

PNSS 20cc/kg/hr IV fast drip upto 3 doses or until

euvolemic Continue IVF depending

on hydration status (mild/moderate/severe)

Increase UO, stable vital signs, increase eGFR

Continue Step A

No improvement, with signs of congestion

Proceed to step B If hypotensive, start inotropes: Dopamine drip if in cold shock,

norepinephrine drip if in warm shock

EUVOLEMIA

PNSS 20cc/kg IV fast drip upto 2 doses

No improvement, with signs of congestion

Proceed to Step C

Increase UO, stable vital signs, increase eGFR

Continue Step A

With signs of congestion

Proceed to Step C

Increase UO, stable vital signs, increase eGFR

Continue step B

HYPERVOLEMIA

+ signs of congestion With crackles

Proceed to Step C

Low eGFR, High BUN, UO decrease 0.5cc/kh/hr

stable vital signs

CXR

NO CONGESTION Step A IV hydration 3-

5cc/kg/hr Monitor UO

Increase UO, stable vital signs, increase eGFR

Continue hydration

No improvement, with signs of congestion

Proceed to step B

No improvement, with progression of congestion

Step C: Do RRT

Increase UO, stable vital signs, increase eGFR

Continue step B

WITH CONGESTION Step B Start furosemide 2-6mg/kg as IV

bolus q6 or drip IVF M x 0.3 + UO Monitor UO

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Step C (Pediatric Patients)

No improvement, with signs of congestion

Proceed to Step C

HEMODIALYSIS

MILD CONGESTION

No acidosis, normal RR + crackles BLF, no desaturation

MODERATE-SEVERE CONGESTION

Intractable acidosis, increased RR Crackles BLF, oxygen-requiring

CAPD

LEPTOSPIROSIS With Suspected Pulmonary Hemorrhage

Continue Observation

Cough, dyspnea, hemoptysis RR > 30 for children > 5yo

> 40 for children 1-5yo

Presence of the following: Chest Xray-Bilateral Infiltrates

PF ratio < 250 OR SaO2< 90% at 6L/min via face

Intubate patient* and hook to mechanical ventilator

Continue methylprednisolone

10-20mg/kg, max 500mg IV for 2 more days then Prednisone 1mg/kg/day x 7 days

Continue Observation Discontinue Steroids

Give Methylprednisolone 10-20mg/kg

Max: 500mg IV

No

Yes

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Appendix

D.L

ep

tosp

iro

sis

Ce

nsus F

orm

at fo

r R

epo

rtin

g

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Appendix E. Criteria for Assisted Ventilation for Leptospirosis Patients

Indications for BIPAP:

Establish need for Ventilatory Assistance in an alert and cooperative patient:

Moderate to severe respiratory distress

Tachypnea (RR>24 breaths/min)

Accessory muscle use or abdominal paradox

pH <7.35, arterial PCO2>45mmHg or arterial PO2/FIO2<200

Exclude patients with contraindications to Non-invasive ventilation:

Respiratory arrest

Medically unstable (septic or cardiogenic shock, uncontrolled upper

gastrointestinal bleeding, uncontrolled arrhythmias)

Unable to protect airway

Excessive secretions

Uncooperative or agitated

Unable to fit mask

Recent upper airway or gastrointestinal surgery

Indications for Intubation:

Hypoxic respiratory failure: PaO2/FiO2 <200 (moderate ARDS) or O2

saturation <90% at 10 L/min face mask with rebreathing bag

Hypercapneic respiratory failure: pH <7.2, PCO2 > 45mmHg

Deterioration of sensorium

Failure of noninvasive ventilation

*Once intubated, co-manage with anesthesiologists for adequate sedation

Indications for ECMO in Leptospirosis patients with pulmonary hemorrhage resulting

in ARDS;

Use of SOFA/ Murray Score to initially evaluate patient

PaO2/FiO2 < 100 on FiO2> 90% and/or Murray score 3-4 despite optimal care

for 6 hours or less. The best outcome in ECMO for adult respiratory failure

occurs when ECMO is instituted early after onset (1-2 days).

CO2 retention on mechanical ventilation despite high Pplat (>30 cm H2O)

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Contraindications for ECMO:

There are no absolute contraindications to ECMO. Each patient is considered

individually with respect to benefits and risks. However, the following may be

considered contraindications if present (based on HEALTHCARE FACILITY

Protocol).

Cardiac arrest

Mechanical ventilation for more than 3 days

CNS hemorrhage

Nonrecoverable comorbidity such as major CNS damage or terminal

malignancy

Age: no specific age contraindication but consider increasing risk with

increasing age

Pancreatic enzymes: Lipase > 2x upper limit of normal

References:

Murray and Nadel’s Textbook of Respiratory Medicine

ELSO Adult Respiratory Failure Guideline

Murray Score

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DEFINITION OF TERMS

Upsurge An increase or an upward surge in the number of leptospirosis patients

requiring hospital admission, wherein the hospital must augment

bedspace availability to accommodate all of the patients

GLOSSARY

ER – Emergency Room HD – Hemodialysis MSSD – Medical Social Services Division OR – Operating Room PD – Peritoneal Dialysis RRT – Renal Replacement Therapy SHO – Senior House Officer

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NOTES

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NOTES

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