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Choice of fluid in sepsis
1. Choice of fluid in sepsis
University of
Copenhagen
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
25. Starch Ringer’s
SF-36 P value
Physical component
summary score
37 (29-48) 40 (32-51) 0.23
Mental component
summary score
45 (36-55) 53 (39-60) 0.01
6S
TRIAL
Reduced QoL at 1-year with starch
Critical Care 2013; 17: R58
26. The 6S summary
6S
TRIAL
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
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. Ratio
CHEST NaCl vs 6% HES130 n=7000 1.2
6S trial Ringer vs 6% HES130 n= 800 1.1
CRYSTMAS NaCl vs 6% HES130 n= 196 1.0
Crystalloid to HES volume ratio in blinded trials
34. • Open-label trial
• ICU patients in shock
• Randomisation by envelopes, fixed block size of 4
• Any colloid (maily HES) vs. any crystalloid (maily
saline)
The CRISTAL trial JAMA Oct. 2013
38. •High risk of bias in 3 domains
•Unblinded
•Uncertain allocation concealment
•Baseline imbalance
The CRISTAL trial JAMA Oct. 2013
39. The effect of bias on mortality in HES trials in
sepsis
RR 1.11 (1.01-1.23), p=0.03
Low risk of method. bias
High risk of method. bias
RR 0.49 (0.28-0.85), p=0.01
Test of heterogeneity
p<0.01
47. Coming trial results…
EARSS - 20% HA vs saline in septic shock
ALBIOS - 20% HA vs saline in severe sepsis
Shall we use albumin in sepsis?
Probably not
These are the characteristics of the interim cohort. I would like to emphasize that the patients are presented as one population since we are still blinded. So, there is 400 patients. 62% were males, and they had a median age of 66. The majority of the patients came to the ICU for medical reasons and 9 out of 10 presented with septic shock. The median SAPS II was 53, which corresponds to a predicted in-hospital mortality of 53 %.
These are the characteristics of the interim cohort. I would like to emphasize that the patients are presented as one population since we are still blinded. So, there is 400 patients. 62% were males, and they had a median age of 66. The majority of the patients came to the ICU for medical reasons and 9 out of 10 presented with septic shock. The median SAPS II was 53, which corresponds to a predicted in-hospital mortality of 53 %.
Det næste skridt i meta-analysen er at kigge på forsøg af høj og lav kvalitet hver for sig. Det er en standardprocedure i meta-analyser og giver jo egentligt ganske god mening.
Forsøgene med lav risiko for bias altså af høj kvalitet viser samlet en 11% relativ overdødelighed, som er statistisk signifikant. Man kan regne ud at det svarer til at hver gang vi giver HES til 32 patienter, er der én der dør alene pga. af det.
Til gengæld viser forsøgene af lav kvalitet dvs. med høj risiko for bias en signifikant nedsat dødelighed. Måske er det ikke så mærkeligt i betragtning af at disse forsøg ikke følger patienterne i særlig lang tid og da de er ublindede giver patienterne meget store doser krystalloid sammenlignet med kolloid.
Intuitivt kan man fornemme at disse 2 resultater er helt forskellige og det bekræftes af den lave p-værdi her. Det betyder altså, at de dårligt designede forsøg har så markant anderledes resultater, at man skal passe på med at tillægge dem for stor vægt.
Renal outcomes.
Development of AKI: We defined this as creatinine above 170 mmol/l OR renal replacement therapy. 32 vs 27%. Not significant.
Two-fold increase in creatinine 41 vs 35%. Some would say that there is a tendency towards a difference.
Renal replacement therapy at any time: 22 vs 16. P of 4% and thus a significant difference. This corresponds to a 35% increased risk of being treated with renal replacement therapy.
Renal outcomes.
Development of AKI: We defined this as creatinine above 170 mmol/l OR renal replacement therapy. 32 vs 27%. Not significant.
Two-fold increase in creatinine 41 vs 35%. Some would say that there is a tendency towards a difference.
Renal replacement therapy at any time: 22 vs 16. P of 4% and thus a significant difference. This corresponds to a 35% increased risk of being treated with renal replacement therapy.
Renal outcomes.
Development of AKI: We defined this as creatinine above 170 mmol/l OR renal replacement therapy. 32 vs 27%. Not significant.
Two-fold increase in creatinine 41 vs 35%. Some would say that there is a tendency towards a difference.
Renal replacement therapy at any time: 22 vs 16. P of 4% and thus a significant difference. This corresponds to a 35% increased risk of being treated with renal replacement therapy.
Det næste skridt i meta-analysen er at kigge på forsøg af høj og lav kvalitet hver for sig. Det er en standardprocedure i meta-analyser og giver jo egentligt ganske god mening.
Forsøgene med lav risiko for bias altså af høj kvalitet viser samlet en 11% relativ overdødelighed, som er statistisk signifikant. Man kan regne ud at det svarer til at hver gang vi giver HES til 32 patienter, er der én der dør alene pga. af det.
Til gengæld viser forsøgene af lav kvalitet dvs. med høj risiko for bias en signifikant nedsat dødelighed. Måske er det ikke så mærkeligt i betragtning af at disse forsøg ikke følger patienterne i særlig lang tid og da de er ublindede giver patienterne meget store doser krystalloid sammenlignet med kolloid.
Intuitivt kan man fornemme at disse 2 resultater er helt forskellige og det bekræftes af den lave p-værdi her. Det betyder altså, at de dårligt designede forsøg har så markant anderledes resultater, at man skal passe på med at tillægge dem for stor vægt.
Renal outcomes.
Development of AKI: We defined this as creatinine above 170 mmol/l OR renal replacement therapy. 32 vs 27%. Not significant.
Two-fold increase in creatinine 41 vs 35%. Some would say that there is a tendency towards a difference.
Renal replacement therapy at any time: 22 vs 16. P of 4% and thus a significant difference. This corresponds to a 35% increased risk of being treated with renal replacement therapy.
Renal outcomes.
Development of AKI: We defined this as creatinine above 170 mmol/l OR renal replacement therapy. 32 vs 27%. Not significant.
Two-fold increase in creatinine 41 vs 35%. Some would say that there is a tendency towards a difference.
Renal replacement therapy at any time: 22 vs 16. P of 4% and thus a significant difference. This corresponds to a 35% increased risk of being treated with renal replacement therapy.
Det næste skridt i meta-analysen er at kigge på forsøg af høj og lav kvalitet hver for sig. Det er en standardprocedure i meta-analyser og giver jo egentligt ganske god mening.
Forsøgene med lav risiko for bias altså af høj kvalitet viser samlet en 11% relativ overdødelighed, som er statistisk signifikant. Man kan regne ud at det svarer til at hver gang vi giver HES til 32 patienter, er der én der dør alene pga. af det.
Til gengæld viser forsøgene af lav kvalitet dvs. med høj risiko for bias en signifikant nedsat dødelighed. Måske er det ikke så mærkeligt i betragtning af at disse forsøg ikke følger patienterne i særlig lang tid og da de er ublindede giver patienterne meget store doser krystalloid sammenlignet med kolloid.
Intuitivt kan man fornemme at disse 2 resultater er helt forskellige og det bekræftes af den lave p-værdi her. Det betyder altså, at de dårligt designede forsøg har så markant anderledes resultater, at man skal passe på med at tillægge dem for stor vægt.
