Computerized Glucose Control in Critically Ill Patients
Condition: Hyperglycemia; Critical Illness
MeSH terms: Hyperglycemia; Critical Illness
Intervention: CGAO-based Glucose Control; Standard-Care Glucose Control
Intervention description: Use of a clinical computerized decision-support system named CGAOtm designed to achieve tight glucose control in various ICU settings, and fine-tuned to reduce glucose variability without increasing the incidence of severe hypoglycemia or nurse workload.
CGAOtm is based on explicit replicable recommendations following each blood glucose measurement for insulin rates and time to next measurement, and reminders, alerts, graphic tools, trends, and individual on-line data aimed at increasing confidence of the nursing staff in the computer protocol and giving care staff a method for controlling the process during the whole ICU stay, according to a "human-in-the-loop" approach.
The algorithm used in the CGAOtm software for the calculation of the recommended insulin rates derived from a PID (Proportional-integral-derivative) controller, a generic control loop feedback mechanism widely used in industrial control.; Patients in the control group will receive conventional insulin therapy using the "usual care" protocol of each participating centre (already used in the centre before the beginning of the trial and targeting blood glucose levels inferior to 180 mg/dl).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2684.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperglycemia; Hypoglycemia; Intensive Care Unit; Glucose Control; Insulin; Computer Protocol; Metabolic Disorders

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 with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software
      is designed to assist physicians and nurses in achieving tight glucose control (defined by a
      target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.