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Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

NCT00135473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-02-11

No results posted yet for this study

Summary

The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

DRUG

10% Hemohes® (10% Hydroxyethyl starch)

DRUG

Sterofundin® (Ringer lactate solution)

DRUG

Actrapid® (Insulin)

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • HemoCue

    collaborator INDUSTRY

  • SepNet - Critical Care Trials Group

    lead OTHER

Principal Investigators

  • Konrad Reinhart, MD · F.-Schiller-University Jena, Germany

  • Thomas Deufel, MD · F.-Schiller-University Jena, Germany

  • Markus Löffler, MD · University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2005-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00135473 on ClinicalTrials.gov