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
  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
Universität Carl-Gustav-Carus
01067 Dresden, Germany
Krankenhaus Dresden Friedrichstadt
01067 Dresden, Germany
Universitätsklinikum Leipzig
04103 Leipzig, Germany
Martin-Luther-Universität Halle/Wittenberg
06097 Halle/Saale, Germany
Universitätsklinikum Jena
07743 Jena, Germany
VIVANTES Klinikum Neukölln II
12313 Berlin, Germany
Charité I Campus Virchow-Klinikum
13353 Berlin, Germany
Städtisches Klinikum Brandenburg GmbH
14770 Brandenburg, Germany
Ernst-Moritz-Arndt-Universität
17487 Greifswald, Germany
Universitätsklinikum Kiel
24105 Kiel, Germany
Medizinische Hochschule Hannover
30625 Hannover, Germany
Georg-August-Universität Göttingen
37075 Göttingen, Germany
Universitätsklinikum der RWTH Aachen
52074 Aachen, Germany
Klinikum Augsburg
86156 Augsburg, Germany
Universität Erlangen-Nürnberg
91054 Erlangen, Germany
HELIOS Klinikum Erfurt
99089 Erfurt, Germany
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:
No publications provided by German Competence Network Sepsis

Additional 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: July 28, 2010
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
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014