Colloids versus Crystalloids: Do we have an answer yet??

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1 Colloids versus Crystalloids: Do we have an answer yet?? Lauralyn McIntyre MD, FRCP(C), MHSc Scientist, Ottawa Hospital Research Institute Assistant Professor, University of Ottawa Department of Epidemiology and Community Medicine Center for Transfusion and Critical Care Research

2 Conflicts of Interest Unrestricted funds CSL Behring

3 The Colloid Crystalloid Question Is one of the oldest Basic yet fundamental question The first intervention given To every patient Often several litres Since fluids critical for achievement of hemodynamic stability, there is a potential for impact on clinically important outcomes

4 Main categories of usual care resuscitation fluids Crystalloid Fluid Normal Saline Ringers Lactate Colloid Fluid Albumin Hydroxyethyl starch

5 Main categories of usual care resuscitation fluids Crystalloid Fluid Normal Saline Ringers Lactate Colloid Fluid Albumin Hydroxyethyl starch Other Colloids: Gelatins Dextrans

6 Components of Normal Saline and Ringers Lactate Na+ mmol/l Osmolarity Clmmol/L K+ mmol/l Ca++ mmol/l Lactate mmol/l Normal Saline Ringers Lactate

7 Albumin Most common human plasma protein (60%) Synthesized in the liver Molecular weight of 66 Kd Responsible for 80% osmotic pressure Available: Iso oncotic (4 5%) Hyper oncotic (20 25%) Quinlan et al, Hepatology, 2005

8 What are hydroxyethyl starch (HES) fluids? Amylopectin starch (branched chain glucose molecules) Hydroxyethylation at C2 and C6 carbon units (substitution) Vary in size ( kd) Vary in the amount of substitution and ratio of substitution

9 Rationale for Resuscitating with Colloids compared to Crystalloids Plasma 3 L ISS 10 L IC 30 L Blood Cells 2 L

10 Rationale for Resuscitating with Colloids compared to Crystalloids Plasma 3 L ISS 10 L IC 30 L Blood Cells 2 L Iso-oncotic colloid

11 Iso-oncotic colloid Hyper-oncotic colloid Rationale for Resuscitating with Colloids compared to Crystalloids Plasma 3 L ISS 10 L IC 30 L Blood Cells 2 L

12 Iso-oncotic colloid Hyper-oncotic colloid Rationale for Resuscitating with Colloids compared to Crystalloids Plasma 3 L ISS 10 L IC 30 L Blood Cells 2 L

13 Iso-oncotic colloid Hyper-oncotic colloid Rationale for Resuscitating with Colloids compared to Crystalloids Plasma 3 L Optimization of the microcirculation?impact on microcirculatory dysfunction ISS 10 L IC 30 L?Modulation of inflammatory response Blood Cells 2 L

14 The Colloid Crystalloid Question Research on this question for several decades And yes, there have been many studies and many systematic reviews

15 Cochrane Systematic Reviews Author/Year Fluids compared # Studies Perel, 2011 Colloids vs Crystalloids 56 Bunn, 2011 Colloid vs Colloid 72 Alderson 2009 Albumin vs no albumin 37 Dart 2010 HES vs other fluid 34

16 Cochrane Systematic Reviews Author/Year Fluids compared # Studies Perel, 2011 Colloids vs Crystalloids 56 Bunn, 2011 Colloid vs Colloid 72 Alderson 2009 Albumin vs no albumin 37 Dart 2010 HES vs other fluid 34 So why are we still studying this question?

17 Small sample size Cochrane Systematic Reviews Single centre Dated resuscitation protocols Insufficient dose Author/Year Fluids compared # Studies Perel, 2011 Colloids vs Crystalloids 56 Surrogate outcomes Bunn, 2011 Colloid vs Colloid 72 Few studies in the critically ill Alderson 2009 Albumin vs no albumin 37 Low methodological rigor (risk of bias high) Dart 2010 HES vs other fluid 34 So why are we still studying this question?

18 SAFE TRIPS II: International cross sectional study 391 ICUs and 25 countries Finfer et al, Critical Care, 2010; 14:R185

19 SAFE TRIPS II: International cross sectional study 391 ICUs and 25 countries Finfer et al, Critical Care, 2010; 14:R185

20 SAFE TRIPS II: International cross sectional study 391 ICUs and 25 countries Finfer et al, Critical Care, 2010; 14:R185

21 SAFE TRIPS II: International cross sectional study 391 ICUs and 25 countries Finfer et al, Critical Care, 2010; 14:R185

22 SAFE TRIPS II: International cross sectional study 391 ICUs and 25 countries Finfer et al, Critical Care, 2010; 14:R185

23 Are colloid fluids better maintained in the intravascular space as compared to

24 RCT/Yr Population Fluid Comparators Ratio Crystalloid/Colloid SAFE/04 VISEP/08 McIntyre/08 Critically ill N = 6997 Severe Sepsis/ Septic Shock N = 537 Septic Shock N = 40 4% albumin vs normal saline 10% HES vs ringers lactate 10% HES vs normal saline Hartog et al, Anesth and Anal 2011, 112:

25 RCT/Yr Population Fluid Comparators Ratio Crystalloid/Colloid SAFE/04 VISEP/08 McIntyre/08 Critically ill N = 6997 Severe Sepsis/ Septic Shock N = 537 Septic Shock N = 40 4% albumin vs normal saline 10% HES vs ringers lactate 10% HES vs normal saline Hartog et al, Anesth and Anal 2011, 112:

26 RCT/Yr Population Fluid Comparators Ratio Crystalloid/Colloid SAFE/04 VISEP/08 McIntyre/08 Critically ill N = 6997 Severe Sepsis/ Septic Shock N = 537 Septic Shock N = 40 4% albumin vs normal saline 10% HES vs ringers lactate 10% HES vs normal saline Hartog et al, Anesth and Anal 2011, 112:

27 RCT/Yr Population Fluid Comparators Ratio Crystalloid/Colloid SAFE/04 VISEP/08 McIntyre/08 Critically ill N = 6997 Severe Sepsis/ Septic Shock N = 537 Septic Shock N = 40 4% albumin vs normal saline 10% HES vs ringers lactate 10% HES vs normal saline? Endothelial Cell Leak Hartog et al, Anesth and Anal 2011, 112:

28 Are there potential harms associated with the use of colloid fluid in the

29 Hydroxyethyl starches Albumin Coagulopathy yes yes Transmission viral infection no yes Anaphylaxis yes (<0.006%) yes (<0.1%) Pruritis yes no Renal Failure yes? Grocott, M, Anesthesia and Analgesia, 2005

30 Hydroxyethyl starches Albumin Coagulopathy yes yes Transmission viral infection no yes Anaphylaxis yes (<0.006%) yes (<0.1%) Pruritis yes no Renal Failure yes? Grocott, M, Anesthesia and Analgesia, 2005

31 Brunkhorst et al, NEJM, 2008

32 Baseline Characteristics Mean (SD) Ringers Lactate N=275 HES N=262 Age 64.9 ± ± 13.3 Sex (male) (%) APACHE II Score 20.3 ± ± 6.7 P value Results (%) *RRT 18.8% 31% Acute renal failure day Mortality 24.1% 26.7% day Mortality 33.9% 41% *RRT = renal replacement therapy Brunkhorst et al, NEJM, 2008

33 VISEP trial: HES dose and RRT Brunkhorst et al, NEJM, 2008

34 VISEP trial: HES dose and RRT Limitations of the VISEP Trial Fluid protocol violations No criteria for dialysis Un-blinded study Brunkhorst et al, NEJM, 2008

35 What evidence related to HES is forthcoming? Trial Population Fluids compared Primary Outcome 6S Severe Sepsis N = 800 Voluven vs Ringers lactate 90 Day Mortality or Dialysis CHEST Critically ill N = 7000 Voluven vs Normal Saline 90 Day Mortality

36 Finfer et al, NEJM 2004; 350:

37

38

39

40

41 Survival in SAFE TBI sub-group (n = 460) Survival 28 Days Survival 24 Months 20.4% 33.2%

42 Survival in SAFE TBI sub-group (n = 460) Survival 28 Days Survival 24 Months 20.4% Severe TBI (N = 290) RR and 95% CI: 1.88 (1.31 to 1.70) 33.2%

43 SAFE TBI comments Post - hoc sub group analysis Co-interventions for TBI not described Biological mechanisms not clear Intracranial hypertension 30% vs 34% albumin vs normal saline

44 Predefined sub-group with severe sepsis n = 1218 Finfer et al, Intensive Care Medicine, published on line, October 6, 2010

45 SAFE Severe Sepsis: Baseline Characteristics Albumin Saline Age 60.5 ± ±17.1 Gender (male) 59.6% 57.1% APACHE II 21.6± ±7.7 Septic Shock 34.8% 37.3% ARDS 6.5% 6.8% Ventilation 56.8% 59.4%

46 SAFE Severe Sepsis: 28 day mortality Finfer et al, Intensive Care Medicine, published on line, October 6, 2010

47 SAFE Severe Sepsis: 28 day mortality Finfer et al, Intensive Care Medicine, published on line, October 6, 2010

48 SAFE Severe Sepsis: 28 day mortality No differences in renal injury between fluid groups Finfer et al, Intensive Care Medicine, published on line, October 6, 2010

49 Maitland et al, NEJM, 2011 FEAST Trial 3141 African children with febrile illness and impaired perfusion Randomized to boluses of 5% albumin, normal saline, or no bolus

50 FEAST Trial 3141 African children with febrile illness and impaired perfusion Randomized to boluses of 5% albumin, normal saline, or no bolus Bolus 5% albumin Bolus normal saline Control 48 hour death 10.6% 10.5% 7.3% 4 week death 12.2% 12.0% 8.7% Neurologic sequlae Increased ICP or pulmonary edema 2.2% 1.9% 2.0% 2.6% 2.2% 1.7% Maitland et al, NEJM, 2011

51 More evidence for albumin in sepsis is coming EARRS Trial ALBIOS Trial PRECISE Trial Populatio n Septic shock within first 6 hours ICU admission Severe Sepsis/Septic Shock within 24 hours in ICU Early Septic shock from the ED Sample Size Interventi on Primary Outcome Open label 100 mls 20% albumin Q8H versus normal saline for first 3 days in ICU 28 Day Mortality Open label Up to 300 mls infused 20% albumin vs crystalloid fluid according to albumin levels in ICU Double blind Head to Head 500 ml boluses 5% albumin versus normal saline starting in ED 28 Day Mortality 90 Day Mortality

52 Colloids versus Crystalloids for Fluid Resuscitation: Do we have the ANSWERS yet? Populations Albumin Hydroxyethyl starch Heterogeneous critically ill Yes Evidence coming Septic shock Evidence coming Evidence coming Trauma SG evidence SG evidence ARDS SG evidence SG evidence Traumatic Brain Injury SG evidence SG evidence Sub Arachnoid Hemorrhage?? SG = evidence from sub group

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