An interventional study of Insulin in Critical Illness, sponsored by University of Liege. Completed at 11 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-27.
Sponsored by University of Liege · Not applicable, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 3,500 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mortality in the Intensive Care Unit (ICU)
Hospital mortality
28 Day mortality
Length of ICU stay
Length of hospital stay
Number of episodes of hypoglycemia and associated clinical signs
Infectious morbidity
Incidence of organ failures
Number of red-cell transfusions
Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
Daily SOFA (Sequential Organ Failure Assessment) Score
This study is completed, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.
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University of Liege