Hydroxyethyl starch and Ringer’s lactate for volume resuscitation in sepsis and septic shock – The BaSES Trial

Abstract

Abstract Study objective: Shock develops in one third of ICU patients. Uncertainty remains about the ideal amount and choice of resuscitation fluid to avoid consequences of fluid overload. Design: The BaSES (Basel Starch Evaluation in Sepsis) Trial is an investigator-initiated, single-centre, randomised controlled clinical trial on volume resuscitation. Setting: We investigated whether volume resuscitation with Hydroxyethyl starch (HES 130/0.4) compared to normal saline (NaCl 0.9%) reduces ICU length of stay. Patients: A total of 244 septic shock patients were randomized (119 to HES, 125 to NaCl). Interventions: Randomization to HES or NaCl for volume resuscitation. Measurements: ICU length of stay (LOS), hospital LOS, ICU mortality, in-hospital mortality, and 1-year mortality, incidence of acute kidney injury (AKI), fluid balance, trajectory of inflammatory parameters, lactate, and SOFA (sequential organ failure assessment) score. Main results: Baseline characteristics and ICU management were comparable among groups. ICU LOS was not significantly shorter with HES (hazard ratio, HR, for ICU discharge alive HES vs. NaCl, 1.11,95% CI 0.83 to 1.49). However, the HES group showed a significantly reduced hospital LOS (HR HES vs. NaCl: 1.48, 95 % CI 1.09 to 2.01, p=0.011). HES did not significantly affect other laboratory values, mortality or renal function. Conclusions: The results of the BaSES trial neither do call for complete suspension of HES from the market, nor do they support a role of HES in volume resuscitation in septic shock. Trial registration: ClinicalTrials.gov Identifier: NCT00273728