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

This study has been completed.
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk A/S
HemoCue Gmbh, Großostheim, Germany
Information provided by:
German Competence Network Sepsis Identifier:
First received: August 24, 2005
Last updated: February 10, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Severe Sepsis Septic Shock Drug: 10% Hemohes® (10% Hydroxyethyl starch) Drug: Sterofundin® (Ringer lactate solution) Drug: Actrapid® (Insulin) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by German Competence Network Sepsis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: April 2003
Estimated Study Completion Date: September 2005
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00135473

Universitätsklinikum der RWTH Aachen
Aachen, Germany, 52074
Klinikum Augsburg
Augsburg, Germany, 86156
VIVANTES Klinikum Neukölln II
Berlin, Germany, 12313
Charité I Campus Virchow-Klinikum
Berlin, Germany, 13353
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany, 14770
Krankenhaus Dresden Friedrichstadt
Dresden, Germany, 01067
Universität Carl-Gustav-Carus
Dresden, Germany, 01067
HELIOS Klinikum Erfurt
Erfurt, Germany, 99089
Universität Erlangen-Nürnberg
Erlangen, Germany, 91054
Greifswald, Germany, 17487
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
Martin-Luther-Universität Halle/Wittenberg
Halle/Saale, Germany, 06097
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Jena
Jena, Germany, 07743
Universitätsklinikum Kiel
Kiel, Germany, 24105
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
German Competence Network Sepsis
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk A/S
HemoCue Gmbh, Großostheim, Germany
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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00135473     History of Changes
Other Study ID Numbers: SEPNET-200304
01 KI 0106 (BMBF)
Study First Received: August 24, 2005
Last Updated: February 10, 2016

Keywords provided by German Competence Network Sepsis:
Severe sepsis
septic shock
volume substitution
intensive insulin therapy

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017