Status:
COMPLETED
Computerized Glucose Control in Critically Ill Patients
Lead Sponsor:
Centre Hospitalier of Chartres
Collaborating Sponsors:
Société Française d'Anesthésie et de Réanimation
Baxter Healthcare Corporation
Conditions:
Hyperglycemia
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to determine whether the use of the CGAOtm software is associated with a decrease in 90-day mortality when compared with the use of standard care methods for glucose control wi...
Detailed Description
Hyperglycemia in response to critical illness has long been associated with adverse outcomes. In 2001, the first "Leuven study", a randomized controlled trial conducted in surgical intensive care pat...
Eligibility Criteria
Inclusion
- At time of the patient's admission to the ICU, the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.
Exclusion
- Age \< 18 years or patient under guardianship.
- Pregnancy.
- Moribund patient or imminent death in the ICU (e.g. patient expected to die in the ICU within 24 hours).
- At time of the patient's admission, the treating physicians are not committed tu full supportive care.
- Patient admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
- Patient admitted to the ICU for hypoglycemia.
- Patient thought to be at abnormally high risk of suffering hypoglycemia (e.g. known insulin secreting tumor or history of unexplained or recurrent hypoglycemia or fulminant hepatic failure).
- Patient who have suffered hypoglycemia without documented full neurological recovery
- Patient is expected to be eating before the end of the day following admission.
- Patient previously enrolled in the CGAO-REA study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
2684 Patients enrolled
Trial Details
Trial ID
NCT01002482
Start Date
October 1 2009
End Date
April 1 2013
Last Update
December 3 2013
Active Locations (35)
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1
C.H.U. Hôpital Nord
Amiens, France, 80054
2
C.H. d'Avignon
Avignon, France, 84902
3
G.H.U. Nord Hôpital Jean Verdier
Bondy, France, 93143
4
Polyclinique Jean Vilar
Bruges, France, 33520