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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00135473
First received: August 24, 2005
Last updated: July 28, 2010
Last verified: February 2006

August 24, 2005
July 28, 2010
April 2003
Not Provided
  • Mortality (28 day)
  • Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Same as current
Complete list of historical versions of study NCT00135473 on ClinicalTrials.gov Archive Site
  • 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
  • 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 HES therapy
  • Frequency of hypoglycemia under intensive insulin therapy
  • Frequency of critical illness polyneuropathy (CIP)
  • 90 day Mortality
Not Provided
Not Provided
 
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • Drug: 10% Hemohes® (10% Hydroxyethyl starch)
  • Drug: Sterofundin® (Ringer lactate solution)
  • Drug: Actrapid® (Insulin)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
September 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00135473
SEPNET-200304, 01 KI 0106 (BMBF)
Not Provided
Not Provided
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
German Competence Network Sepsis
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP