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

Primary Purpose

Severe Sepsis, Septic Shock

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
10% Hemohes® (10% Hydroxyethyl starch)
Sterofundin® (Ringer lactate solution)
Actrapid® (Insulin)
Sponsored by
SepNet - Critical Care Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Severe sepsis, septic shock, volume substitution, intensive insulin therapy, colloids, crystalloids, outcome, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum der RWTH Aachen
  • Klinikum Augsburg
  • VIVANTES Klinikum Neukölln II
  • Charité I Campus Virchow-Klinikum
  • Städtisches Klinikum Brandenburg GmbH
  • Krankenhaus Dresden Friedrichstadt
  • Universität Carl-Gustav-Carus
  • HELIOS Klinikum Erfurt
  • Universität Erlangen-Nürnberg
  • Ernst-Moritz-Arndt-Universität
  • Georg-August-Universität Göttingen
  • Martin-Luther-Universität Halle/Wittenberg
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Jena
  • Universitätsklinikum Kiel
  • Universitätsklinikum Leipzig

Outcomes

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

Full Information

First Posted
August 24, 2005
Last Updated
February 10, 2016
Sponsor
SepNet - Critical Care Trials Group
Collaborators
German Federal Ministry of Education and Research, B. Braun Melsungen AG, Novo Nordisk A/S, HemoCue Gmbh, Großostheim, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00135473
Brief Title
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
SepNet - Critical Care Trials Group
Collaborators
German Federal Ministry of Education and Research, B. Braun Melsungen AG, Novo Nordisk A/S, HemoCue Gmbh, Großostheim, Germany

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Severe sepsis, septic shock, volume substitution, intensive insulin therapy, colloids, crystalloids, outcome, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
10% Hemohes® (10% Hydroxyethyl starch)
Intervention Type
Drug
Intervention Name(s)
Sterofundin® (Ringer lactate solution)
Intervention Type
Drug
Intervention Name(s)
Actrapid® (Insulin)
Primary Outcome Measure Information:
Title
Mortality (28 day)
Title
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Secondary Outcome Measure Information:
Title
Frequency of acute kidney failure
Title
Time until hemodynamic stabilization
Title
Frequency of therapy with vasopressors (in days)
Title
Course of SOFA sub-scores
Title
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Title
Frequency of hypoglycemia under intensive insulin therapy
Title
Frequency of critical illness polyneuropathy (CIP)
Title
90 day Mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Reinhart, MD
Organizational Affiliation
F.-Schiller-University Jena, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Deufel, MD
Organizational Affiliation
F.-Schiller-University Jena, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markus Löffler, MD
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
VIVANTES Klinikum Neukölln II
City
Berlin
ZIP/Postal Code
12313
Country
Germany
Facility Name
Charité I Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Städtisches Klinikum Brandenburg GmbH
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
Facility Name
Krankenhaus Dresden Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universität Carl-Gustav-Carus
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
HELIOS Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universität Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Martin-Luther-Universität Halle/Wittenberg
City
Halle/Saale
ZIP/Postal Code
06097
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitätsklinikum Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18184958
Citation
Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
Results Reference
derived

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

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