Bleeding and risk of death with hydroxyethyl starch in severe sepsis: post hoc analyses of a randomized clinical trial
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Nicolai Haase Jørn Wetterslev Per Winkel Anders Perner
ORIGINAL ARTICLE
Bleeding and risk of death with hydroxyethyl starch in severe sepsis: post hoc analyses of a randomized clinical trial
Abstract Purpose: We aimed to characterize the degree and clinical importance of bleeding in patients treated with hydroxyethyl starch (HES). Methods: In post hoc analyses, we examined the associations For the 6S Trial Group and the Scandinavian Critical Care Trials Group. 6S between fluid assignment, hemostatic trial ClinicalTrials.gov number variables, bleeding events, transfuNCT00962156. sions, and death among 798 patients Electronic supplementary material with severe sepsis randomized to fluid The online version of this article resuscitation with HES 130/0.42 ver(doi:10.1007/s00134-013-3111-9) contains supplementary material, which is available sus Ringer’s acetate. We used Cox regression analysis adjusted for fluid to authorized users. assignment and baseline characteristics. Results: Overall, 93 (23 %) patients assigned to HES versus 60 N. Haase ()) A. Perner (15 %) patients assigned to Ringer’s Department of Intensive Care, Copenhagen acetate bled in the ICU (relative risk University Hospital, Rigshospitalet, 2100 (RR) 1.55; 95 % CI 1.16–2.08; Copenhagen, Denmark P = 0.003). Of these, 38 and 25 (RR e-mail: nicolai.rosenkrantz.segelcke.haase 1.52; 95 % CI 0.94–2.48; P = 0.09), @regionh.dk Tel.: ?45-3545-4131 respectively, had severe bleeding Fax: ?45-3545-2736 (intracranial or concomitant transfusion with three units of red blood J. Wetterslev P. Winkel cells). Most patients bled in the first Copenhagen Trial Unit, Centre for Clinical days after randomization when most Intervention Research, Copenhagen trial fluid was given. The hazards University Hospital, Rigshospitalet, 2100 ratios for occurrence of any bleeding Copenhagen, Denmark Received: 5 June 2013 Accepted: 10 September 2013 Published online: 1 October 2013 Ó Springer-Verlag Berlin Heidelberg and ESICM 2013
Introduction Hydroxyethyl starch (HES) was the most commonly used colloid in a recent worldwide point prevalence study of resuscitation in intensive care units (ICU) [1]. Systematic reviews report that HES affects hemostasis more than other fluids, but most clinical trials in these reviews assessed the former high molecular weight HES in
and severe bleeding in patients treated with HES versus Ringer’s acetate were 1.70 (95 % CI 1.23–2.36; P = 0.001) and 1.55 (95 % CI 0.93–2.56; P = 0.09), respectively. The adjusted hazard ratios for death among patients with any bleeding and severe bleeding compared to those without bleeding were 1.36 (95 % CI 1.04–1.79; P = 0.03) and 1.74 (95 % CI 1.20–2.53; P = 0.004), respectively. Conclusions: In post hoc analyses of patient with severe sepsis, treatment with HES increased the risk of bleeding which was associated with increased risk of death. HESinduced bleeding complications may negatively affect outcome in patients with severe sepsis. Keywords Hydroxyethyl starch Sepsis Coagulopathy Bleeding Mortality
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