BaSES Trial: Basel Starch Evaluation in Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Sepsis Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HES, Septic shock, resuscitation

study group with HES 6%

Group Type ACTIVE_COMPARATOR

hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

Intervention Type DRUG

hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline

Interventions

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hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline

Intervention Type DRUG

Other Intervention Names

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Voluven Ringer's lactate NaCl 0.9%

Eligibility Criteria

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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