BaSES Trial: Basel Starch Evaluation in Sepsis

This study has been completed.
Sponsor:
Collaborator:
Fresenius AG
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00273728
First received: January 6, 2006
Last updated: August 11, 2011
Last verified: August 2011

January 6, 2006
August 11, 2011
May 2005
June 2010   (final data collection date for primary outcome measure)
  • Intensive Care length of stay [ Time Frame: time to discharge from the Intensive care unit ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: time to discharge from the hospital ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: intesive care, hospital and one year mortality ] [ Designated as safety issue: No ]
  • Intensive Care length of stay
  • Hospital length of stay
  • Mortality
Complete list of historical versions of study NCT00273728 on ClinicalTrials.gov Archive Site
  • Kidney function [ Time Frame: at intensive care discharge and after one year ] [ Designated as safety issue: Yes ]
  • Lung function [ Time Frame: during intensive care ] [ Designated as safety issue: No ]
  • Kidney function
  • Lung function
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sepsis
  • Severe Sepsis
  • Septic Shock
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%
Active Comparator: HES, Septic shock, resuscitation
study group with HES 6%
Intervention: Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
May 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00273728
Swissmedic: 2005DR3123, EKBB: EK 244/04
No
PD Dr M. Siegemund, University Hospital Basel
University Hospital, Basel, Switzerland
Fresenius AG
Principal Investigator: Martin Siegemund, MD Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
University Hospital, Basel, Switzerland
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP