Abstract
IntroductionInadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients.MethodsIn 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.Results174 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.ConclusionSignificantly 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.govNCT00464204
Highlights
Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients
The secondary objectives of this study were to explore the efficacy of hydroxyethyl starch (HES) vs. NaCl regarding time taken to achieve initial HDS, total quantity of study drug infused over four consecutive days in the intensive care unit (ICU), length of stay (LOS) in the ICU and in hospital and area under the curve (AUC) of Sequential Organ Failure Assessment (SOFA) score from screening to day 4
Fluid intake prior to randomization was 35.5 ± 25.3 ml/kg in the HES group and Related to pre-existing renal impairment - Known serum creatinine >3.39 mg/dla - Anuria lasting more than 8 hours despite fluid resuscitation - Requirement for renal support
Summary
Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients. Optimized management in the first 6 hours has been reported to significantly reduce mortality in patients with severe sepsis and septic shock [2]. Adequate fluid resuscitation is a major step in the management of severe sepsis/shock and is recommended worldwide to improve prognosis [3]. Some data suggest hyperoncotic colloids and starches with a molar substitution >0.4 may be harmful for the kidney in patients with septic shock [4,5,6]. Third generation hydroxyethyl starch (HES), the so-called tetrastarch (molar degree of substitution 0.4 and medium molecular weight of 130 kDa) with a reportedly improved safety profile [7,8], has led to renewed interest in the use of HES for volume therapy
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