NCT00107601

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
7 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

June 27, 2008

Status Verified

February 1, 2006

First QC Date

April 5, 2005

Last Update Submit

June 26, 2008

Conditions

Critical Illness

Keywords

GlucoseGlucose ControlInsulinInsulin therapyCritically illIntensive Care

Outcome Measures

Primary Outcomes (1)

  • Mortality in the Intensive Care Unit (ICU)

Secondary Outcomes (10)

  • Hospital mortality

  • 28 Day mortality

  • Length of ICU stay

  • Length of hospital stay

  • Number of episodes of hypoglycemia and associated clinical signs

  • +5 more secondary outcomes

Interventions

InsulinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

C.H.U. Erasme

Brussels, Belgium

Location

University Hospital Gasthuisberg

Leuven, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Hopital Raymond Poincare

Garches, France

Location

Université Joseph Fournier

Grenoble, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Universität Ulm

Ulm, Germany

Location

Rabin Medical Center

Patah Tiqwa, Israel

Location

V.U.Z. Amsterdam

Amsterdam, Netherlands

Location

Hospital Universitario General Negrin

Las Palmas de Gran Canaria, Spain

Location

C.H.U. Vaudois

Lausanne, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 26541344DERIVED

  • 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.

    PMID: 19636533DERIVED

MeSH Terms

Conditions

Critical IllnessInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Philippe Devos

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2005

First Posted

April 6, 2005

Study Start

October 1, 2004

Study Completion

May 1, 2006

Last Updated

June 27, 2008

Record last verified: 2006-02

Locations

IL(1)FR(3)BE(3)NL(1)ES(1)CH(1)DE(1)