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

April 5, 2005
June 26, 2008
October 2004
Not Provided
Mortality in the Intensive Care Unit (ICU)
Same as current
Complete list of historical versions of study NCT00107601 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Critical Illness
Drug: Insulin
Not Provided
Preiser JC, Devos P, Ruiz-Santana S, Mélot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chioléro R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. Epub 2009 Jul 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3500
May 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Switzerland,   France,   Spain,   Israel,   Germany,   Netherlands
 
NCT00107601
2004-003914-40, EUDRACT Number: 200400391440
Not Provided
Not Provided
University Hospital of Liege
Belgian Government
Principal Investigator: Philippe Devos University of Liege
University Hospital of Liege
February 2006

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