BaSES Trial: Basel Starch Evaluation in Sepsis

Study Overview
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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

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

Conditions
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Sepsis, Severe Sepsis, Septic Shock

Intervention / Treatment
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* Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline


Participation Criteria
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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 Exclusion Criteria: Pregnancy Age below 18 Allergy against Hydroxyethyl starch Chronic renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HES, Septic shock, resuscitation<br>study group with HES 6% | Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline<br>* hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care length of stay |  | time to discharge from the Intensive care unit | 
| Hospital length of stay |  | time to discharge from the hospital | 
| Mortality |  | intesive care, hospital and one year mortality | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function |  | at intensive care discharge and after one year | 
| Lung function |  | during intensive care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality