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| Sponsor: | University Hospital of Liege |
|---|---|
| Collaborator: |
Belgian Government |
| Information provided by: | University Hospital of Liege |
| ClinicalTrials.gov Identifier: | NCT00107601 |
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 |
| Estimated Enrollment: | 3500 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | May 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Philippe Devos | University of Liege |
More Information
| 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 |
|
Glucose Glucose Control Insulin |
Insulin therapy Critically ill Intensive Care |
|
Critical Illness Disease Attributes Pathologic Processes Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |