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Scandinavian Starch for Severe Sepsis/Septic Shock Trial

NCT00962156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2012-07-10

No results posted yet for this study

Summary

* By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

DRUG

6% Hydroxyethyl starch 130/0.4

Infusion for volume expansion in the ICU

DRUG

Ringers acetate

Infusion for volume expansion in the ICU

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Anders Perner

    lead OTHER

Principal Investigators

  • Anders Perner, MD, PhD · ICU, Rigshospitalet, University of Copenhagen

  • Nicolai Haase, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00962156 on ClinicalTrials.gov