Research
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
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
Critical Care 2012, 16:R94 doi:10.1186/cc11358
Published: 24 May 2012Abstract
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.
