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Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 versus 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study.

Abstract : ABSTRACT: INTRODUCTION: Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients. METHODS: in order to compare the hemodynamic efficacy and safety of 6% HES 130/0.4 and NaCl 0.9% for HDS in patients with severe sepsis, we designed a prospective, multicenter, active-controlled, double-blind, randomized study in Intensive care units. RESULTS: 174 out of 196 patients reached HDS (88 and 86 patients for HES and NaCl, respectively). Significantly less HES was used to reach HDS versus NaCl (1,379 886 ml in the HES group and 1,709 1,164 ml in the NaCl group [Mean difference = -331 1,033, 95% CI -640 to -21, p=0.0185). Time to reach HDS was 11.8 10.1 hours versus 14.3 11.1 hours for HES and NaCl, respectively. Total quantity of study drug infused over four consecutive days, ICU and hospital LOS, and area under the curve of SOFA Score were comparable. Acute renal failure occurred in 24 (24.5%) and 19 (20%) patients for HES and NaCl, respectively (p=0.454). There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality, coagulation, or pruritus up to 90 days after treatment initiation. CONCLUSION: Significantly less volume was required to achieve HDS for HES versus NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups.
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Submitted on : Friday, June 8, 2012 - 5:09:14 PM
Last modification on : Wednesday, August 19, 2020 - 11:58:38 AM
Long-term archiving on: : Monday, September 10, 2012 - 12:10:39 PM

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Bertrand Guidet, Olivier Martinet, Thierry Boulain, Francois Philippart, Jean Poussel, et al.. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 versus 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study.. Critical Care, BioMed Central, 2012, 16 (3), pp.R94. ⟨10.1186/cc11358⟩. ⟨inserm-00706029⟩

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