title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00464204.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Guidet
authors.forename: Olivier
authors.initials: O
authors.lastname: Martinet
authors.forename: Thierry
authors.initials: T
authors.lastname: Boulain
authors.forename: Francois
authors.initials: F
authors.lastname: Philippart
authors.forename: Jean François
authors.initials: JF
authors.lastname: Poussel
authors.forename: Julien
authors.initials: J
authors.lastname: Maizel
authors.forename: Xavier
authors.initials: X
authors.lastname: Forceville
authors.forename: Marc
authors.initials: M
authors.lastname: Feissel
authors.forename: Michel
authors.initials: M
authors.lastname: Hasselmann
authors.forename: Alexandra
authors.initials: A
authors.lastname: Heininger
authors.forename: Hugo
authors.initials: H
authors.lastname: Van Aken
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006439:Hemodynamics / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018805:Sepsis / Q000175:diagnosis* / Q000378:metabolism / Q000628:therapy*; D012965:Sodium Chloride / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: C485123:HES 130-0.4; D006895:Hydroxyethyl Starch Derivatives; D012965:Sodium Chloride