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

Further study details as provided by University Hospital of Liege:

Primary Outcomes: Mortality in the Intensive Care Unit (ICU)
Secondary Outcomes: 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
Expected Total Enrollment:  3500

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Belgium
      Centre Hospitalier Universitaire de Liège, LIEGE,  4000,  Belgium
      C.H.U. Erasme, Bruxelles,  Belgium
      University Hospital Gasthuisberg, Leuven,  Belgium
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

Study chairs or principal investigators

Philippe Devos,  Principal Investigator,  University of Liege   

Study ID Numbers:  2004-003914-40; EUDRACT Number: 200400391440
Last Updated:  July 3, 2006
Record first received:  April 5, 2005
ClinicalTrials.gov Identifier:  NCT00107601
Health Authority: European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2006-11-21