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

February 10, 2016 updated by: SepNet - Critical Care Trials Group

Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.

In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Universitatsklinikum der RWTH Aachen
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Berlin, Germany, 12313
        • VIVANTES Klinikum Neukölln II
      • Berlin, Germany, 13353
        • Charité I Campus Virchow-Klinikum
      • Brandenburg, Germany, 14770
        • Stadtisches Klinikum Brandenburg GmbH
      • Dresden, Germany, 01067
        • Krankenhaus Dresden Friedrichstadt
      • Dresden, Germany, 01067
        • Universität Carl-Gustav-Carus
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Erlangen, Germany, 91054
        • Universität Erlangen-Nurnberg
      • Greifswald, Germany, 17487
        • Ernst-Moritz-Arndt-Universität
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen
      • Halle/Saale, Germany, 06097
        • Martin-Luther-Universität Halle/Wittenberg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07743
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Kiel
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Known allergy against hydroxyethyl starch
  • Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion
  • Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)
  • Intracerebral hemorrhage
  • Severe head trauma with edema
  • FiO2 at time of study inclusion > 0,7
  • Heart failure (New York Heart Association [NYHA] IV)
  • Enrolment in another interventional study
  • Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
  • Do not resuscitate (DNR) order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Secondary Outcome Measures

Outcome Measure
Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
Course of SOFA sub-scores
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Frequency of hypoglycemia under intensive insulin therapy
Frequency of critical illness polyneuropathy (CIP)
90 day Mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SepNet - Critical Care Trials Group

Collaborators

Novo Nordisk A/S
German Federal Ministry of Education and Research
B. Braun Melsungen AG
HemoCue Gmbh, Großostheim, Germany

Investigators

  • Study Chair: Konrad Reinhart, MD, F.-Schiller-University Jena, Germany
  • Study Director: Thomas Deufel, MD, F.-Schiller-University Jena, Germany
  • Study Director: Markus Löffler, MD, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (ESTIMATE)

August 26, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEPNET-200304
  • 01 KI 0106 (BMBF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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