Normoglycemia and Neurological Outcome
Summary
Brain injury patients who meet defined criteria will be assigned to intensive insulin treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary outcome measure will be neurological outcome at 12 months according to Karnofsky Performance Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+ moderate disability), unfavorable (severely disabled+ vegetative state), and dead. Secondary outcome measures will be blood glucose levels and death.The investigators will also record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction, ventricular arrhythmias, and pneumonia.
Timeline
- Start
- 2007-01
- Primary completion
- 2014-12
- Completion
- 2015-12
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow enrollment”
registry analysis (superiority test); Intensive IV Insulin vs Convention Insulin Treatment; p = 0.49; t-test, 2 sided NCT01137773 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Intravenous |