Impact of the Use of a Computerized Protocol for Glucose Control Named CGAOtm on the Outcome of Critically Ill Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 2,684
- Locations
- 70
- Primary Endpoint
- All-cause 90-day Mortality
Study Overview
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 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.
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 patients comparing a strategy based on a nurse-driven protocol for insulin therapy in order to maintain normal blood glucose levels [80 - 110 mg/dl] with standard care defined at the time as intravenous insulin started only when blood glucose level exceeded 215 mg/dl and then adjusted to keep blood glucose level between 180 and 200 mg/dl, showed a reduction in hospital mortality by one third.
The results of this trial have been enthusiastically received and rapidly incorporated into guidelines, such as the Surviving Sepsis Campaign in 2004, and now endorsed internationally by numerous professional societies.
However, subsequent randomized controlled trials have failed to confirm a mortality benefit with intensive insulin therapy among critically ill patients, in whom stress hypoglycemia is common. Moreover the Normoglycemia in Intensive Care Evaluation - Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study, an international multicentre trial involving 6104 patients, the largest trial of insulin therapy to date, showed a lower 90-day mortality in the control group targeted blood glucose levels inferior to 180 mg/dl when compared to the intervention group with tight glucose control [80 - 110 mg/dl].
In addition, many studies and meta-analyses have reported high rates of hypoglycemia with tight glucose control. Consequently, considerable controversy has emerged as to whether tight glucose control is warranted in all critically ill patients especially as tight glucose control (without appropriate computer protocol) causes a significant increase in nurse workload.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
All-cause 90-day Mortality
Time Frame: Day 90
Secondary Outcomes
- All-cause 28-day Mortality(Day 28)
- Intensive Care Unit Free Days(28 days)
- Severe Hypoglycemia(Date of discharge from the ICU)
- Incidence of Nosocomial Bacteriemia(Date of discharge from the ICU)
- All-cause Intensive Care Unit Mortality(Date of discharge from the ICU)
- Time Spent in Blood Glucose Target(Day of discharge from the ICU)
- Hospital Length of Stay(Date of discharge from the hospital)
- All-cause In-hospital Mortality(Day of discharge from the hospital)
- Intensive Care Unit Length of Stay(Date of discharge from the ICU)
Investigators
Dr Pierre KALFON
principal investigator
Centre Hospitalier of Chartres