Trial | NCT00273728  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hydroxyethyl starch ...

  • Study Participants

    231
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
Study Started
May 31
2005
Primary Completion
Jun 30
2010
Study Completion
May 31
2011
Last Update
Aug 12
2011
Estimate

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

  • Other names: Voluven, Ringer's lactate, NaCl 0.9%

HES, Septic shock, resuscitation Active Comparator

study group with HES 6%

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
No Results Posted