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

Sponsor
University of Liege (Other)
Overall Status
Completed
CT.gov ID
NCT00107601
Collaborator
Belgian Government (Other)
3,500
11
19
318.2
16.8

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2004
Study Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Mortality in the Intensive Care Unit (ICU) []

Secondary Outcome Measures

  1. Hospital mortality []

  2. 28 Day mortality []

  3. Length of ICU stay []

  4. Length of hospital stay []

  5. Number of episodes of hypoglycemia and associated clinical signs []

  6. Infectious morbidity []

  7. Incidence of organ failures []

  8. Number of red-cell transfusions []

  9. Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy []

  10. Daily SOFA (Sequential Organ Failure Assessment) Score []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 C.H.U. Erasme Bruxelles Belgium
2 University Hospital Gasthuisberg Leuven Belgium
3 Centre Hospitalier Universitaire de Liège Liege Belgium 4000
4 Hopital Raymond Poincare Garches France
5 Université Joseph Fournier Grenoble France
6 Institut Gustave Roussy Villejuif France
7 Universität Ulm Ulm Germany
8 Rabin Medical Center Patah Tiqwa Israel
9 V.U.Z. Amsterdam Amsterdam Netherlands
10 Hospital Universitario General Negrin Las Palmas de Gran Canaria Spain
11 C.H.U. Vaudois Lausanne Switzerland

Sponsors and Collaborators

  • University of Liege
  • Belgian Government

Investigators

  • Principal Investigator: Philippe Devos, University of Liege

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00107601
Other Study ID Numbers:
  • 2004-003914-40
  • EUDRACT Number: 200400391440
First Posted:
Apr 6, 2005
Last Update Posted:
Jun 27, 2008
Last Verified:
Feb 1, 2006
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2008