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Hot Topics.
FFICM Preparation Day London March 9th 2016
Rob Mac Sweeney
http://bit.do/CCR-FFICM16
Paul Young | Wellington
Saline or PlasmalyteIs SPLIT the Solution
Hot Topics
•2016
•2015
•2014
•2013
•2012
•Major Research
•Major Guidelines
Major Research Studies2016
Sepsis 3DefinitionsProcess
Delphi ProcessDatabase validation
Screening with qSOAFIdentify with SOAF? Advance
DIABOLOFrench multi-centre RCTEarly metabolic alkalosis382 patients
No separation MV | pH | PaCO2
↔ duration ventilation↔ duration weaning↓ bicarb & days with alkalosis
Major Research Studies2015
HEATParacetamol is harmful ?1g IV Paracetamol 6° or placebo700 ptsGroups well balanced↔ temperature (0.2°C)↔ ICU free days (23 v 22)Immunomodulatory effect ?
PROPPRPragmatic multicentre RCT680 severely ill trauma patients1:1:1 with 1:1:2 FFP / Plt / RC↔ mortality:
Day 1Day 30
Reduced exsanguination
deaths1:1:2 group “caught up”
SPLITCluster, crossover RCT0.9% Saline vs Plasmalyte2,278 ptsAll fluid administrative
purposes2000 ml each↔ AKI 9.2% v 9.6%Pilot study
EUROTHERM> 20 mmHg for > 5 minutes32°C – 35°C vs standard mgtStage 2 387 patients∆ 2.14°C | ↓ stage 2 failure acOR 1.53 poor outcome GOS-
ETiming of intervention ?
ABLEIs fresh blood better than old ?Young RBCs vs standard RBCs2430 patientsRBCs: 6 days vs 22 days90 day mortality: 37% vs 35%No 2° outcome differencesTRIGGER | RECESS
EPO-TBIEPO pleotropic effects40,000 IU EPO x 3 or placeboWithholding criteria606 patients↔ GOS-E 1 - 4: 44% vs 45%↔ 6/12 mortality 11% vs 16%↔ DVT 16% vs 18%
ProMISeOpen label, pragmatic RCTEarly septic shock
EGDT: SpO2 | ScvO2 | CVP |
MAP | Hb1,260 patientsSome separation↔ 90 day mortality: 29% vs
29%
FLORALIOpen label, multi-centre RCTFM vs HFNO vs NIVSpO2 > 92%310 patients↔D28 reintubation 47 v 38 v
50%↓ ICU mortality 19 v 11 v 25%↓ D90 mortality 23 v 12 v 28%
3SitesOpen label, RCT 10 French ICUs
Subclavian v I Jugular v FemoralCRBSI & symptomatic DVTExperienced clinicians3,471 catheters in 3,027 patients1.5 v 3.6 v 4.6 per 1000 cath
dayMechanical Complications
2.1% v 1.4% v 0.7%
Amato StudyPost hoc review of 9 RCTsMultilevel Mediation AnalysisFunctional Lung SizeΔP = (Pplt – PEEP) = (Vt
/CRS)
Vt / Pplat / PEEP →ΔP
ΔP 7 cmH20 = ↑41% mortality
Requires validation
Chlorhexidine BathingPragmatic, Cluster Randomized Crossover study
9340 patientsOnce daily 2% chlorhexidine2 x 10 week periods each↔ infections
55 vs 602.86 vs 2.90 / 1000 pt days
Major Research Studies2014
ALBIOSMulticentre Open Label RCT1795 patients with sepsis /
shock20% albumin + crystal vs crystalTarget serum albumin > 30g/l↔ 28 day mortality
Albumin: 31.8% vs 32%↔ 90 day mortality
Albumin: 41.1% vs 43.6%
ARISE Australian / NZ RCTEGDT vs Usual CareRivers algorithm1600 patients with septic shock↔ 90 mortality
EGDT 18.6% vs 18.8%EGDT - ↑ fluids, vasopressors,
RC, dobutamine
ProCESSAmerican multicentre RCT Testing Rivers EGDT protocolEDGT vs Standard vs Usual
care1341 patients with septic shock↔ day 60 mortality
21% vs 18.2% vs 18.9%↔ day 90 or 1 year mortality
CALORIES Pragmatic, open label RCTEnteral vs Parenteral nutritionCould be fed by either route2400 emergency ICU pts↔ Day 30 mortality
PN: 33.1% vs EN: 34.2%PN – less hypos or vomiting
– no effect on infection
CIRC Mechanical CPR vs Manual CPRUSA / European - OOHCA4753 randomized, 522 excluded↔ ROSC: 28.6% v 32.3%↔ 24 hour survival: 21.8% v 25%↔ Hosp discharge: 9.4% vs 11%
LINC European open label RCTMechanical CPR & defibrillation2589 OOHCA patients↔ 4 hr survival: 23.6% vs 23.7%↔ CPC 1-2 survival
At ICU / Hospital dischargeAt 1 or 6 month
HARP-2 Multicentre, UK/Ireland RCTSimvastatin vs Placebo540 patients with ARDS↔ Ventilator-free days↔ Non-pulmonary organ
failure -free days↔ 28 day mortality
METAPLUS European multi-centre RCT301 pts expected ventilated >3/7Immune enhancing nutrientsHigh protein diet both groups↔ new infections (53% vs 52%)↑ 6/12 mortality with IMN
54% vs 35%
PEITHO European Multi-centre RCT1,006 pts intermediate risk PETenecteplase & heparin vs
placebo & heparin↓ Death / CVS decompensation
2.6% vs 5.6%↔ Deaths: 1.2% vs 1.8%;
P=0.42↑ Stroke: 2.4% v 0.2%; ↑
Bleeding
SEPSISPAMMulti-centre open label RCT776 pts with septic shockMAP 80 - 85 vs 65 – 70↔ D28 mortality 36.6% vs 34%↔ D90 mortality 43.8% vs 42.3%↔ serious adverse event↑ AF with higher BP↑ RRT with lower BP chronic
HTN
TRISSEuropean multi-centre RCT1005 pts septic shock & anaemiaTransfuse Hb <9 g/dl vs <7 g/dlLess blood given (median 4 vs 1)↔D90 mortality (45% vs 43%)↔ischaemia / adverse events
VITdAL-ICUAustrian single centre RCT492 white ICU pts Vit D deficientVit D vs Placebo↔ Hosp LOS 20 vs 19 days↔ Hosp / 6/12 mortalitySeverely deficient subgroup
↓ Hosp mortality 28% vs 46%↔ mortality at 6 months
Major Research Studies2013
TTM StudyMulti-centre RCT
950 OOHCA Patients
33°C vs 36°C
↔ All cause mortality
50% vs 48%
↔ Poor neuro function
54% vs 52%
Kim StudyPrehospital cooling
1,359 OOHCA patients
↔ Survival to hosp discharge
VF 63% vs 64%
nonVF 19% vs 16%
↔ Good neuro recovery
VF 57% vs 62%
nonVF 14% vs 13%
CATIS Study4,071 patients
Within 48 hrs ischemic stroke
Nonthrombolysed and ↑SBP
↑ BP Rx vs no BP Rx
BP control effective
↔ death and major disability
• 14 days / hosp discharge
• 3 months
INTERACT2Early ICH & ↑SBP
SBP <140 mmHg vs <180
2,839 pts
Aggressive BP control lead to
Trend for adverse events
↓ modified Rankin scores
↔ mortality
CRISTAL Stratified, open label RCTAny colloid vs any crystalloid2857 pts with hypovolaemic shock↔ 28 day mortality
25.4% vs 27%Less deaths with colloids at D90
30.7% vs 34.2%Less vasopressors / ventilation
TracMan909 intubated patients
Tracheostomy timing
≤ 4 days vs > 10 days
↔ Mortality / ICU LOS
↔ Complications
Only 45% late group received trache
β Blockade in Septic Shock154 septic pts with ↑HR & ↑dose
NA
Esmolol vs standard Rx
Esmolol
↓ HR / lactate / Norad / Fluids
↑ SVI / LVSWI
↓ D28 mortality (49% vs 80%)
STATIN-VAP300 patients suspected VAP
Simvastatin 60 mg vs placebo
Study stopped early for futility
↔ 28 mortality
↔ Duration MV
↔ Δ SOFA
↑ mortality in statin naïve
21.5% vs 13.8%; p=0.054
VSE Study 268 cardiac arrest ptsAdrenaline/Vasopressin/Methylpred
acutely & hydrocortisone later
VSE associated with improved
ROSC (84% vs 66%)
Good neuro recovery
14% vs 5%
21% vs 8%
(post resuscitation shock)
PROSEVA466 patients with severe ARDS
Prone vs supine position
Prone position associated with
↓ mortality D28: 16% vs 33%
↓ mortality D90: 24% vs 41%
↓ cardiac arrests
↔ complications
VILLANEAU• 921 pts with upper GI bleed
• Hb <7g/dL vs Hb <9g/dL transfusion
triggers
• Restrictive strategy:
• ↓ number of pts receiving
transfusion (15% vs 51%)
• ↑probability survival
• ↓ Less rebleeding / AEs
REDOXS1,223 pts with MOF
Glutamine & antioxidants
Glutamine:
↑ mortality
D28 (34% vs 27%; p=0.05)
D90 (44% vs 37%; p=0.02)
Antioxidants ineffective
↔ Mortality / Other endoints
OSCILLATE 548 pts with moderate-to-severe
ARDS
Trial terminated early
↑mortality 47% vs 35%
HFOV associated with
↑ sedation requirements
↑ neuromuscular blockade
↑ vasopressor support
OSCAR795 pts with moderate-to-severe
ARDS
↔ Mortality 41% vs 41%
↔ Duration antimicrobials
↔ Duration pharmacological
vasoactive support
↔ LOS ICU or Hospital
CRICS452 ventilated pts
No gastric volume monitoring
• ↔VAP (15.8% vs 16.7%)
• ↔ ICU-acquired infections
• ↔ Duration MV / ICU or Hospital
LOS
• ↑calorific goal (OR 1.77)
SUNSET-ICUSingle-centre, block, randomised
trial
Resident nighttime intensivist
↔ ICU LOS
↔ Mortality
↔ Other endpoints
Early Parenteral Nutrition
Early PN versus starvation
1,372 patients
Standard group: 40 % unfed
↔ 60 day mortality
↔ LOS – ICU or Hospital
PN: ↓ duration ventilation
ReversalRetrospective observational
Looked at 10 years of NEJM
publications
Medical reversals – current practice
inferior to a prior standard
146/363 studies
40%
Major Research Studies2012
EN vs EN & PN305 critically ill patients
Day 3 & received <60% calorific goal
EN plus PN to achieve 100% calorific
target vs EN alone
EN plus PN associated with
↑ Calories: 28 vs 20 kcal/kg
↓ Infection: 27% vs 38%
Best TRIP324 pts severe TBI
ICP guided vs clinical and imaging
guided management
↔ Composite of functional &
cognitive measures
↔ 6 month mortality (ICP
39% vs C&I: 41%)
↔ Length of stay
CARRESS
SLEAP Study423 pts
Protocolised sedation vs PS plus daily
sedation break
↔ Time to extubation
↔ ICU LOS / Hospital LOS
↔ Delirium / Unintended
extubations
PS & DSB: ↑sedation / nursing
CHEST study7000 ICU pts
Fluid resuscitation with
6% HES 130/0.4 vs 0.9% saline
↔ Mortality (HES 18% vs 17%)
↔ LOS – ICU / Hospital
HES associated with increased
↑ RRT (7% vs 5.8%; RR 1.21)
↑ Pruritus / Rash / Liver failure
6S Study804 severe sepsis pts
Fluid resuscitation
130/0.4 HES vs Ringer's acetate
HES associated with
↑ D90 death (51% vs 43%)
↑ RRT (22% vs 16%)
↑ bleeding (10 v 6%,p=0.09)
IABP-II Study600 pts with acute MI & cardiogenic
shock
IABP vs no IABP
↔ D30 death (IABP 40 v 41%)
↔ Time to CVS stabilisation
↔ ICU LOS
↔ Catecholamines therapy
PROWESS SHOCK Study1,697 pts with septic shock
↔ 28 day mortality
APC 26.4% vs 24.2%
↔ 90 day mortality
34.1% vs 32.7%
No subgroup effect seen
Berlin Definition of ARDS
MASH-21,204 pts within 4 days of
aneurysmal SAH
MgSO4 (64 mmol/day) vs placebo
↔Functional outcome
↔90 day mortality
MgSO4 26% vs 25%
PRODEX / MIDEXMIDEX (n=500)
Dexmedetomidine v Midaz
Dexmedetomidine:
↓ duration ventilation
↑ patient interaction
↑ hypotension / bradycardia
↔ time at target sedation
↔ ICU / Hosp LOS / death
PRODEX / MIDEXPRODEX (n=437)
Dexmedetomidine v Propofol
Dexmedetomidine:
↑ patient interaction
↔ time at target sedation
↔ Duration ventilation
↔ ICU / Hosp LOS // Death
Fever Control200 pts with septic shock requiring
vasopressors
External cooling (36.5 to 37°C) vs not
Cooling was associated with
Early ↓ vasopressors
↑ ICU shock reversal
↓ 14 day mortality
EDEN• 1000 pts early ALI
• Initial trophic EN vs full EN
Trophic feeding Δ -900 kcal/day
↔ Ventilator free days
↔ 60 day mortality
↔ Infectious complications
Full EN: ↑ GI complications
LIFENOX8,307 acutely ill medical patients with
graduated compression stockings
subcutaneous enoxaparin (40 mg
daily) vs. placebo
↔D30 death (4.9% vs 4.8%)
↔Bleeding (0.4% versus 0.3%)
BALTI-2
• 326 pts with ARDS
• salbutamol (15 μg/kg/h) vs. placebo
• Trial stopped early for safety
• ↑Mortality 34% vs 23%
Risk ratio 1.47
Good Luck.
@critcarereviewshttp://bit.do/CCR-
FFICM16