Overview

BaSES Trial: Basel Starch Evaluation in Sepsis

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Fresenius AG
Criteria
Inclusion Criteria:

- Patients with suspected or proven infection and 2 of the following 6 criteria:

- Body temperature <36 or >38.3° celsius

- Heart rate > 90 beats/min

- Tachypnea > 20/min or a arterial pCO2 below 4.25 kPa

- White blood cell count higher than 12.000 or below 4.000 or more than 10% immature
forms

- Systolic blood pressure <90 mmHg or mean arterial pressure < 65 mmHg

- Altered mental state or oliguria

Exclusion Criteria:

- Pregnancy

- Age below 18

- Allergy against Hydroxyethyl starch

- Chronic renal insufficiency