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

Critical Illness Clinical Trial

Official title:

A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107601
• Other study ID #: 2004-003914-40
• Secondary ID: EUDRACT Number:
• Status: Completed
• Phase: N/A
• First received: April 5, 2005
• Last updated: June 26, 2008
• Start date: October 2004
• Est. completion date: May 2006

Study information

• Verified date: February 2006
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
Belgium	C.H.U. Erasme	Bruxelles
Belgium	University Hospital Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liege
France	Hopital Raymond Poincare	Garches
France	Université Joseph Fournier	Grenoble
France	Institut Gustave Roussy	Villejuif
Germany	Universität Ulm	Ulm
Israel	Rabin Medical Center	Patah Tiqwa
Netherlands	V.U.Z. Amsterdam	Amsterdam
Spain	Hospital Universitario General Negrin	Las Palmas de Gran Canaria
Switzerland	C.H.U. Vaudois	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Liege	Belgian Government

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in the Intensive Care Unit (ICU)
Secondary	Hospital mortality
Secondary	28 Day mortality
Secondary	Length of ICU stay
Secondary	Length of hospital stay
Secondary	Number of episodes of hypoglycemia and associated clinical signs
Secondary	Infectious morbidity
Secondary	Incidence of organ failures
Secondary	Number of red-cell transfusions
Secondary	Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
Secondary	Daily SOFA (Sequential Organ Failure Assessment) Score