BaSES Trial: Basel Starch Evaluation in Sepsis

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Severe Sepsis; Septic Shock; Sepsis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00273728

EKBB: EK 244/04

Swissmedic: 2005DR3123

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 1 patient group

HES, Septic shock, resuscitation

Active Comparator group

Description:

study group with HES 6%

Treatment:

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