drugset / Trial / NCT01137773

Normoglycemia and Neurological Outcome

NCT01137773

Phase 4 Terminated 56 enrolled University of Louisville
RandomizedParallel-groupSingle-blindPrevention

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Intravenous