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

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. Identifier: NCT00135473
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : February 11, 2016
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk A/S
HemoCue Gmbh, Großostheim, Germany
Information provided by:
SepNet - Critical Care Trials Group

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
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
Study Start Date : April 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

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

Secondary Outcome Measures :
  1. Frequency of acute kidney failure
  2. Time until hemodynamic stabilization
  3. Frequency of therapy with vasopressors (in days)
  4. Course of SOFA sub-scores
  5. Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
  6. Frequency of hypoglycemia under intensive insulin therapy
  7. Frequency of critical illness polyneuropathy (CIP)
  8. 90 day Mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00135473

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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
SepNet - Critical Care Trials Group
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk A/S
HemoCue Gmbh, Großostheim, Germany
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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 automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00135473    
Other Study ID Numbers: SEPNET-200304
01 KI 0106 (BMBF)
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by SepNet - Critical Care Trials Group:
Severe sepsis
septic shock
volume substitution
intensive insulin therapy
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Insulin, Globin Zinc
Hydroxyethyl Starch Derivatives
Hypoglycemic Agents
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes