Phase 3
N=2,684
Computerized Glucose Control in Critically Ill Patients
Hyperglycemia · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT01002482 ↗Enrolled (actual)
2,684
Serious AEs
1.0%
Results posted
Dec 2013
Primary outcome: Primary: All-cause 90-day Mortality — 431; 447 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CGAO-based Glucose Control (Device); Standard-Care Glucose Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre Hospitalier of Chartres
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause 90-day Mortality |
431; 447 | — |
| SECONDARY All-cause 28-day Mortality |
326; 328 | — |
| SECONDARY All-cause Intensive Care Unit Mortality |
302; 310 | — |
| SECONDARY All-cause In-hospital Mortality |
376; 393 | — |
| SECONDARY Intensive Care Unit Free Days |
14; 13 | — |
| SECONDARY Time Spent in Blood Glucose Target |
— | — |
| SECONDARY Severe Hypoglycemia |
174; 79 | — |
| SECONDARY Hospital Length of Stay |
20; 20 | — |
| SECONDARY Intensive Care Unit Length of Stay |
9; 8 | — |
| SECONDARY Incidence of Nosocomial Bacteriemia |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT01002482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.