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
  Purpose

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


Condition Intervention Phase
Sepsis
Severe Sepsis
Septic Shock
Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 231
Study Start Date: May 2005
Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HES, Septic shock, resuscitation
study group with HES 6%
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273728

Locations
Switzerland
Medical ICU, Univesity Hospital Basel
Basel, Switzerland, CH-4031
Surgical ICU, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Fresenius AG
Investigators
Principal Investigator: Martin Siegemund, MD Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
  More Information

Additional Information:
Publications:
Responsible Party: PD Dr M. Siegemund, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00273728     History of Changes
Other Study ID Numbers: Swissmedic: 2005DR3123, EKBB: EK 244/04
Study First Received: January 6, 2006
Last Updated: August 11, 2011
Health Authority: Switzerland: Swissmedic
Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Basel, Switzerland:
Hydroxyethyl Starch
shock, septic
infusion, intravenous
mortality

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 29, 2014