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Choice of fluid in sepsis

Choice of fluid in sepsis. Anders Perner Dept of Intensive Care, Rigshospitalet, University of Copenhagen Scandinavian Critical Care Trials Group www.ssai.info/research/SCCTG Intensive Care Medicine http://icmjournal.esicm.org/index.html

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Choice of fluid in sepsis

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  1. Choice of fluid in sepsis Anders Perner Dept of Intensive Care, Rigshospitalet, University of Copenhagen Scandinavian Critical Care Trials Group www.ssai.info/research/SCCTG Intensive Care Medicine http://icmjournal.esicm.org/index.html COIs - Research support from B Braun, Fresenius, CSL Behring Honoraria from Ferring, LFP University of Copenhagen

  2. ICM 2013;39:165 CCM 2013;41:580

  3. 6S TRIAL

  4. 6S TRIAL Investigator-initiated & publicly-funded

  5. 6S TRIAL Investigator-initiated & publicly-funded High internal validity Pre-publiced protocol and SAP Five-fold blinding 100% follow-up

  6. 6S TRIAL Investigator-initiated & publicly-funded High internal validity Pre-publiced protocol and SAP Five-fold blinding 100% follow-up High external validity Pragmatic design 50% non-university hospitals 66% inclusion rate, simple inclusion and few exclusion criteria

  7. Inclusion criteria 6S TRIAL Adult patients in the ICU AND Fulfil severe sepsis criteria within 24 h AND Need for fluid resuscitation

  8. Masked trial fluid up till 33 ml/IBW-kg/day Trial fluid # 1 Trial fluid # 2 Trial fluid # X 6S TRIAL Intervention 6% HES 130/0.42 in Ringer’s acetate (Tetraspan) or Ringer’s acetate (Sterofundin)

  9. Baseline characteristics 6S TRIAL Starch Ringers Numbers 398 400 Age 66 (56-75) 67 (56-76) Time from ICU admin to rando 4 (1-13) 4 (1-13) SAPS II 50 (40-60) 51 (39-62) Acute kidney injury 36% 35% Shock 84% 84% Values are medians (IQRs) or numbers (%)

  10. Trial fluid 6S TRIAL

  11. Fluid volumes and balances 6S TRIAL

  12. 180 g HES

  13. Starch increased…. 6S TRIAL

  14. Number needed to harm…. 6S TRIAL 13

  15. 6S TRIAL ICM 2013; 39: 1936

  16. Meta-analysis of HES130 vs. crystalloid/HA in sepsisMortality RR 1.1 (1.0-1.2) BMJ 2013; 346: f839

  17. Starch increased…. 6S TRIAL

  18. 6S TRIAL Earlier use of RRT with starch ESICM 2013

  19. RRT and risk of death 6S TRIAL NEJM 2012

  20. RRT and risk of death 6S TRIAL NEJM 2012

  21. Meta-analysis of HES130 vs. crystalloid/HA in sepsisRRT RR 1.4 (1.1-1.7) BMJ 2013; 346: f839

  22. 6S TRIAL Starch increased bleeding ICM 2013 39(12):2126

  23. 6S TRIAL Earlier bleeding with starch P=0.001 ICM 2013 39(12):2126

  24. Bleeding and risk of death 6S TRIAL ICM 2013 39(12):2126

  25. 6S TRIAL Reduced QoL at 1-year with starch Critical Care 2013; 17: R58

  26. 6S TRIAL The 6S summary Higest methodological standards Tested starch in clinical practice Included patients fairly early Gave fluid volumes early and well within the labelled dose Biological plausibility – Cause-and-effect

  27. A ‘correct’ indication for starch?

  28. Existing data do not support ‘correct’ indication for starch Haase et al. Critical Care 2013

  29. A safe starch dose?

  30. A safe starch dose? Higher volume Lower volume Cochrane CD007594

  31. CHEST: HES 130/0.4 vs saline in 7,000 general ICU patients Increased use of RRT, RBCs and SAEs with mean 500 ml of starch Myburgh et al. NEJM 2012

  32. Crystalloid to HES volume ratio in blinded trials Ratio CHEST NaCl vs 6% HES130 n=7000 1.2 6S trial Ringer vs 6% HES130 n= 800 1.1 CRYSTMASNaCl vs 6% HES130 n= 196 1.0

  33. New data

  34. The CRISTAL trial JAMA Oct. 2013 • Open-label trial • ICU patients in shock • Randomisation by envelopes, fixed block size of 4 • Any colloid (maily HES) vs. any crystalloid (maily saline)

  35. Primary outcome

  36. 90-day mortality

  37. The CRISTAL trial JAMA Oct. 2013 • High risk of bias in 3 domains • Unblinded • Uncertain allocation concealment • Baseline imbalance

  38. The effect of bias on mortality in HES trials in sepsis Low risk of method. bias RR 1.11 (1.01-1.23), p=0.03 High risk of method. bias RR 0.49 (0.28-0.85), p=0.01 Test of heterogeneity p<0.01

  39. ICM 2013;39:165 CCM 2013;41:580

  40. ICM 2013;39:165 CCM 2013;41:580

  41. Shall we use albumin in sepsis?

  42. HES comparator / Non-septic patient Fraud? Kids HES comparator / Non-septic patient

  43. SAFE septic pts – outcome Finfer S. ICM 2010

  44. Multivariate analyses Finfer S. ICM 2010

  45. Shall we use albumin in sepsis? Probably not Coming trial results… EARSS - 20% HA vs saline in septic shock ALBIOS - 20% HA vs saline in severe sepsis

  46. Until then.....................crystalloids for sepsis

  47. www.NEJM.org Sept 24th 2013

  48. 3 2 4 1 www.NEJM.org Sept 24th 2013

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