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

This study has been completed.

Sponsors and Collaborators: German Competence Network Sepsis
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk
HemoCue Gmbh, Großostheim, Germany
Information provided by: German Competence Network Sepsis
ClinicalTrials.gov Identifier: NCT00135473
  Purpose

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 III

MedlinePlus related topics:   Sepsis   

ChemIDplus related topics:   Insulin    Starch    Hetastarch    Lactic acid    Ammonium lactate    Ringer's lactate    Ringer's lactate solution   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135473

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

Sponsors and Collaborators
German Competence Network Sepsis
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk
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    
  More Information


Click here for more information about the VISEP study by SepNet  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Study ID Numbers:   SEPNET-200304, 01 KI 0106 (BMBF)
First Received:   August 24, 2005
Last Updated:   February 15, 2006
ClinicalTrials.gov Identifier:   NCT00135473
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Hetastarch
Insulin
Inflammation

Additional relevant MeSH terms:
Hypoglycemic Agents
Pathologic Processes
Therapeutic Uses
Hematologic Agents
Blood Substitutes
Physiological Effects of Drugs
Plasma Substitutes
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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