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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

Bertrand Guidet123*, Olivier Martinet4, Thierry Boulain5, Francois Philippart67, Jean François Poussel8, Julien Maizel9, Xavier Forceville10, Marc Feissel11, Michel Hasselmann4, Alexandra Heininger12 and Hugo Van Aken13

Author Affiliations

1 Réanimation médicale, Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Antoine, 184 rue du Faubourg Saint Antoine, Paris, F-75012, France

2 UPMC Université Paris 06, 4 Place Jussieu, Paris, 75005, France

3 Inserm, Unité de Recherche en Épidémiologie Systèmes d'Information et Modélisation (U707), Paris, F-75012, France

4 Réanimation Médicale, Hôpital Civil de Strasbourg, Place de l'Hôpital, 67091, Strasbourg, France

5 Réanimation Polyvalente, Hôpital de la Source, 1Rue Porte Madeleine, Orléans, 45032, France

6 Réanimation Polyvalente, Hôpital Saint-Joseph, 185 Rue Raymond Losserand, Paris, 75014, France

7 Université Paris Descartes, 12 Rue de L'École de Médecine, Paris, 75006, France

8 Réanimation Polyvalente, Centre Hospitalier de Metz, 1 Place Philippe de Vigneulles, Metz cedex, 57038, France

9 Réanimation Médicale, Hôpital Sud, Avenue René Laënnec-Salouël, Amiens, 80054, France

10 Réanimation, CH Meaux, 6-8 Rue Saint-Fiacre, Meaux, 77104, France

11 Réanimation et Maladies Infectieuses, Site de Belfort, CH de Belfort-Montbeliard, 14 Rue de Mulhouse, Belfort, 90016, France

12 Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum, Hoppe-Seyler-Straße 3, Tübingen, 72076, Germany

13 Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin der Westf, Wilhelms-Universität, Albert-Schweitzer-Str. 33, Münster, 48149, Germany

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Critical Care 2012, 16:R94  doi:10.1186/cc11358

Published: 24 May 2012

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 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.

ClinicalTrials.gov

NCT00464204