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BaSES Trial: Basel Starch Evaluation in Sepsis (BaSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00273728
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : August 12, 2011
Sponsor:
Collaborator:
Fresenius AG
Information provided by:
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Starch

Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. Intensive Care length of stay [ Time Frame: time to discharge from the Intensive care unit ]
  2. Hospital length of stay [ Time Frame: time to discharge from the hospital ]
  3. Mortality [ Time Frame: intesive care, hospital and one year mortality ]

Secondary Outcome Measures :
  1. Kidney function [ Time Frame: at intensive care discharge and after one year ]
  2. Lung function [ Time Frame: during intensive care ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273728


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

Publications:

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Responsible Party: PD Dr M. Siegemund, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00273728    
Other Study ID Numbers: Swissmedic: 2005DR3123
EKBB: EK 244/04
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by University Hospital, Basel, Switzerland:
Hydroxyethyl Starch
shock, septic
infusion, intravenous
mortality
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes