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