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

AbstractINTRODUCTION:
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 vs. 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 vs. 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 vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups.
CLINICALTRIALSGOV:
NCT00464204.
AuthorsBertrand Guidet, Olivier Martinet, Thierry Boulain, Francois Philippart, Jean François Poussel, Julien Maizel, Xavier Forceville, Marc Feissel, Michel Hasselmann, Alexandra Heininger, Hugo Van Aken
JournalCritical care (London, England) (Crit Care) Vol. 16 Issue 3 Pg. R94 (May 24 2012) ISSN: 1466-609X [Electronic] England
PMID22624531 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • HES 130-0.4
  • Hydroxyethyl Starch Derivatives
  • Sodium Chloride
Topics
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Fluid Therapy (methods)
  • Hemodynamics (drug effects, physiology)
  • Humans
  • Hydroxyethyl Starch Derivatives (administration & dosage)
  • Male
  • Middle Aged
  • Prospective Studies
  • Sepsis (diagnosis, metabolism, therapy)
  • Sodium Chloride (administration & dosage)
  • Treatment Outcome

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