NCT00273728

BaSES Trial: Basel Starch Evaluation in Sepsis

Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Sepsis
• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline	hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline

Timeline

• Start date: 2005-05-01
• Primary completion: 2010-06-01
• Completion: 2011-05-01
• First posted: 2006-01-09
• Last updated: 2011-08-12

Locations

2 sites across 1 country: Switzerland