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

NCT ID: NCT00107601

Last Updated: 2008-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-05-31

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.

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.

Conditions

Critical Illness

Keywords

Glucose; Glucose Control; Insulin; Insulin therapy; Critically ill; Intensive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belgian Government

OTHER_GOV

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Principal Investigators

Philippe Devos

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

C.H.U. Erasme

Brussels, , Belgium

University Hospital Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Hopital Raymond Poincare

Garches, , France

Université Joseph Fournier

Grenoble, , France

Institut Gustave Roussy

Villejuif, , France

Universität Ulm

Ulm, , Germany

Rabin Medical Center

Patah Tiqwa, , Israel

V.U.Z. Amsterdam

Amsterdam, , Netherlands

Hospital Universitario General Negrin

Las Palmas de Gran Canaria, , Spain

C.H.U. Vaudois

Lausanne, , Switzerland

Countries

Belgium; France; Germany; Israel; Netherlands; Spain; Switzerland

References

Crosara IC, Melot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.

Reference Type: DERIVED

PMID: 26541344 (View on PubMed)

Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero 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. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.

Reference Type: DERIVED

PMID: 19636533 (View on PubMed)

Other Identifiers

EUDRACT Number: 200400391440

Identifier Type: -

Identifier Source: secondary_id

2004-003914-40

Identifier Type: -

Identifier Source: org_study_id