Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

This study has been completed.
Sponsor:
Collaborator:
Belgian Government
Information provided by:
University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT00107601
First received: April 5, 2005
Last updated: June 26, 2008
Last verified: February 2006
  Purpose

Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).

This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.


Condition Intervention
Critical Illness
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Mortality in the Intensive Care Unit (ICU)

Secondary Outcome Measures:
  • Hospital mortality
  • 28 Day mortality
  • Length of ICU stay
  • Length of hospital stay
  • Number of episodes of hypoglycemia and associated clinical signs
  • Infectious morbidity
  • Incidence of organ failures
  • Number of red-cell transfusions
  • Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
  • Daily SOFA (Sequential Organ Failure Assessment) Score

Estimated Enrollment: 3500
Study Start Date: October 2004
Estimated Study Completion Date: May 2006
Detailed Description:

Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications. We hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients. This hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit, which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia. However, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management. The present prospective, randomized, controlled and multicentric study, will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) and will be powered to detect a 4% decrease in absolute intensive care unit (ICU) mortality. Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in ICU and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.

  Eligibility

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

Inclusion Criteria:

  • All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason

Exclusion Criteria:

  • Absence of the informed consent (as approved by the local ethical committee).
  • Life expectancy lower than 24 hours, as estimated upon admission.
  • Therapeutic limitation upon admission in ICU
  • Pregnancy
  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: NCT00107601

Locations
Belgium
C.H.U. Erasme
Bruxelles, Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liege, Belgium, 4000
France
Hopital Raymond Poincare
Garches, France
Université Joseph Fournier
Grenoble, France
Institut Gustave Roussy
Villejuif, France
Germany
Universität Ulm
Ulm, Germany
Israel
Rabin Medical Center
Patah Tiqwa, Israel
Netherlands
V.U.Z. Amsterdam
Amsterdam, Netherlands
Spain
Hospital Universitario General Negrin
Las Palmas de Gran Canaria, Spain
Switzerland
C.H.U. Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
University Hospital of Liege
Belgian Government
Investigators
Principal Investigator: Philippe Devos University of Liege
  More Information

No publications provided by University Hospital of Liege

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00107601     History of Changes
Other Study ID Numbers: 2004-003914-40, EUDRACT Number: 200400391440
Study First Received: April 5, 2005
Last Updated: June 26, 2008
Health Authority: European Union: European Medicines Agency

Keywords provided by University Hospital of Liege:
Glucose
Glucose Control
Insulin
Insulin therapy
Critically ill
Intensive Care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014