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: February 10, 2016
Last verified: February 2016
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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
Ernst-Moritz-Arndt-Universität
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
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
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

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016