Clinical trial NCT00107601: Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Official title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Glucose
Glucose Control
Insulin
Insulin therapy
Critically ill
Intensive Care
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Belgian Government
First posted: 2005-04-06
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mortality in the Intensive Care Unit (ICU)
Secondary outcomes:
measure: Hospital mortality
measure: 28 Day mortality
measure: Length of ICU stay
measure: Length of hospital stay
measure: Number of episodes of hypoglycemia and associated clinical signs
measure: Infectious morbidity
measure: Incidence of organ failures
measure: Number of red-cell transfusions
measure: Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
measure: Daily SOFA (Sequential Organ Failure Assessment) Score
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: C.H.U. Erasme
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Grenoble
country: France
facility: Université Joseph Fournier
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Ulm
country: Germany
facility: Universität Ulm
city: Patah Tiqwa
country: Israel
facility: Rabin Medical Center
city: Amsterdam
country: Netherlands
facility: V.U.Z. Amsterdam
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario General Negrin
city: Lausanne
country: Switzerland
facility: C.H.U. Vaudois
Study officials:
affiliation: University of Liege
name: Philippe Devos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.