Sepsis Clinical Trial
Official title:
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial
Background: In patients with severe sepsis and septic shock early aggressive volume
replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions.
The role of modern, low molecular weight, starch preparations and their influence on the
course of disease is not determined yet.
Hypothesis: The purpose of this study is to determine wether initial infusion therapy with
Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care
Unit and hospital length of stay without impairment of renal function
Design: Double-blind, randomized, controlled monocentric study
Setting: Intensive Care Units of a University Hospital
Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock
Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW
130, substitution 0.4) in the first five days of intensive care treatment.
Parameter:
- Intensive Care length of stay
- Hospital length of stay
- Mortality
- Kidney function
Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay.
Unpaired t-Test for kidney function parameters.
Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl
starch group
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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