Sheet1

Chart1

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Actual Recruitment

Target Recruitment

Week of Study

Number Recruited

SAFE Study: Actual v Target Recruitment

weekly rando

week beginning12/1119/1126/113/1210/1218/0325/031/048/0415/0422/0429/046/0513/0520/0527/053/0610/0617/0624/061/078/0715/0722/0729/075/0812/0819/0826/082/099/0916/0923/0930/097/1014/1021/1028/104/1111/1118/1125/112/129/1216/1223/1230/126/0113/0120/0127/013/0210/0217/0224/023/0310/0317/0324/0331/037/0414/0421/0428/045/0512/0519/0526/052/069/0616/06Totalno. wks activemin pred totalmax wkly predmin wkly predaverage per wk since 24/6/02monthly min predicted

10AUCK81391189128586121161421275361736715041371677101067591315791091012121174395137811.857.40932

11MH64759646495543478794558166342234504344232672365130225512929.155.72525

20JHH5488987549575684651055751175436756462768433115653510835857869133362603399.055.65625

28RPAH64251095108135768691110111488109911711123998568977101187116987851077106259410539946511673458.255.16822

31RMH25254969981038108111513721161716816107121212131110121410911661061488101110888814108910131212171110121246566745110.776.731129

32ARMC2513005210985686849591068947557871062549859576569976713711613513111316111013419141512975377047110.776.73829

42PAH5271281275959769128646641395101116951477712115415312279108897797628362116794496460315.089.42741

50FRE3734924410754473546392730357467576755975001203032542531174265221264642075.173.23414

52WESTERN23343244334932577346104986551576711621320004646533263365865475802876241710.776.73529

55RNSH29930641175106510411371011116526991310776101094511791286000947111311710512111211814812912565036946410.776.73829

60RHH556553508545667799113839368688447554457576892610158764262875543551355653067.544.71620

78NEPEAN0785788614112118135101014101011124101171475157889911683000611128967104111281358869869508643458.625.38823

81ALF-GEN500407874753284966411061214345675474398751265712674298956911432115768745513866952212.127.57633

82ALF-SURG00020445294439551534372402492373466545500152131322130142760326434732228691744.042.52311

103RAH91011781112101061010713137111415895910101091313116101711103910671078471398586589966121411131195886443110.776.73929

104RDH75133866674102101146761335534375347821541710000233848859264126336675304651754.312.69512

105ST G33108688468668792996661013365115121886610875952424566425451088683815565398653618.885.55624

Total920281622059839777104102948612186109851031541161291451381131141021331299913213211614010214811511612112313196881149465737876113103118961091001229512411911511713111012911413112911775007,00015899114428

max forecast (calc from ICU predictions)383041461132108117128128137137137137137137137137137158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158158

minimum forecast (calc from ICU predictions)241919297206879808086868686868686868699999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999

numbers randomised929577375951542373344115156177117979181,0041,1131,1981,3011,4551,5711,7001,8451,9832,0962,2102,3122,4452,5742,6732,8052,9373,0533,1933,2953,4433,5583,6743,7953,9184,0494,1454,2334,3474,4414,5064,5794,6574,7334,8464,9495,0675,1635,2725,3725,4945,5895,7135,8325,9476,0646,1956,3056,4346,5486,6796,8086,9257,0007,0007,000

max cumulative predicted38671081371431752834015286567939301,0671,2041,3411,4781,6141,7511,8882,0462,2042,3622,5202,6782,8362,9933,1513,3093,4673,6253,7833,9414,0994,2564,4144,5724,7304,8885,0465,2045,3625,5205,6775,8355,9936,1516,3096,4676,6256,7836,9417,0987,2567,4147,5727,7307,8888,0468,2048,3628,5198,6778,8358,9939,1519,3099,4679,6259,7839,94010,098

min cumulative predicted2442611071181372052843644445296157007868719571,0421,1281,2141,3131,4111,5101,6091,7071,8061,9052,0032,1022,2012,3002,3982,4972,5962,6942,7932,8922,9903,0893,1883,2863,3853,4843,5823,6813,7803,8783,9774,0764,1744,2734,3724,4704,5694,6684,7674,8654,9645,0635,1615,2605,3595,4575,5565,6555,7535,8525,9516,0496,1486,2476,345

week number1234567891011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859606162636465666768697071727374

date (week beginning)18/3/0225/3/021/4/028/4/0215/4/0222/4/0229/4/026/5/0213/5/0220/5/0227/5/023/6/0210/6/0217/6/0224/6/021/7/028/7/0215/7/0222/7/0229/7/025/8/0212/8/0219/8/0226/8/022/9/029/9/0216/9/0223/9/0230/9/027/10/0214/10/0221/10/0228/10/024/11/0211/11/0218/11/0225/11/022/12/029/12/0216/12/0223/12/0230/12/026/1/0313/1/0320/1/0327/1/033/2/0310/2/0317/2/0324/2/033/3/0310/3/0317/3/0324/3/0331/3/037/4/0314/4/0321/4/0328/4/035/5/0312/5/0319/5/0326/5/032/6/039/6/0316/6/0323/6/0330/6/037/7/03

weekly prediction (average based on previous weekly counts)154135133136136133130126127127125125126125126125126125125125125125124121121119119117116116115115114114114113113113113113113113113114114114114115115115115115115115115

cum prediciton7,0407,1557,2707,3857,5007,615

SAFE FDA MARCH 05

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of SydneyNumber randomized = 7000 Asignado a la albmina = 3497 (100%)

Allocated to saline = 3500 (100%) Perdido en el seguimiento = 24 (0,7%) denegar o retirar el consentimiento = 20 (0,6%) la falta de aleatorizacin supone = 4 (0.1%) Lost to follow-up = 40 (1.1%) Refused or withdrawn consent = 37 (1.0%) Randomization failure assumed = 3 (0.1%)Analyzed = 3473 (99.3%)Analyzed = 3460 (98.9%) Al azar dos veces en 28 das perodo = 3, (albumin =2, saline = 1) Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney*

SAFE FDA MARCH 05

Caracterstica de lnea de baseAlbuminSaline Edad en aos - media SD58.6 19.158.5 18.7 Genero femenino N (%)1424 (40.7)1376 (39.3) Motivo de ingreso a ICU N (%)Surgical1,473 (42.9)1,465 (42.7)Medical1,955 (57.1)1,958 (57.3)Pre-defined sub-groups N (%)Trauma 597 (17.4)590 (17.2)Severe sepsis603 (18.1)615 (18.4)ARDS61 (1.8)66 (1.9)APACHE II score - mean SD18.7 7.919.0 8.0

*

SAFE FDA MARCH 05

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney

Caracterstica de lnea de baseAlbuminSalinePhysiological variable - mean SDHeart rate (beats per minute)91.4 23.592.3 23.5Mean arterial pressure (mmHg)77.8 16.478.2 16.3Central venous pressure (mmHg)9.0 4.78.6 4.6 Urine output (mL last hour)89.7 132.495.0 161.4Serum albumin (g/L)

Treatment at baseline27.4 7.827.7 7.9

Receiving mechanical ventilation N (%)2186 (63.8)2217 (64.8)Receiving renal replacement therapy N (%)45 (1.3)41 (1.2)Received albumin in prior 72 hours N (%)127 (3.7)135 (3.9)

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney*

SAFE FDA MARCH 05

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of SydneyRatio of albumin to saline for first four days = 1:1.4 (Mean difference per randomized patient for first four days 749 mL)P

Mortality in patients with and without severe sepsis.

24.bin

SAFE FDA MARCH 05

Study Conclusions En poblacin heterognea de pacientes de la UCI, la albmina y solucin salina son clnicamente equivalentes tratamientos.El uso de cualquiera de los resultados en:mortalidad similartiempo similar a la muerte de los que muerenuso similar de la ventilacin mecnica y la terapia de reemplazo renalincidencia similar de nuevos fallos orgnicosUCI similar y la estancia hospitalaria Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney

SAFE FDA MARCH 05

Anlisis mas extenso Por albmina lnea de basecohorte de sepsisEl trauma y la lesin cerebral traumticaLos patrones de disfuncin de rganos

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney

Australian and New Zealand Intensive Care Society Clinical Trials GroupAustralian Red Cross Blood ServiceThe George Institute for International Health University of Sydney*

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