Normoglycemia and Neurological Outcome

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• non-traumatic SAH, ICH, or TBI

• Glasgow Coma Scale between 6 and 14

• admitted to an ICU of University of Louisville Hospital

Exclusion Criteria:

• Patients <18 and >80 years

• GCS Motor score <4 or an overall GCS score of 15

• diabetic patients who suffer from dialysis-dependent diabetic nephropathy

• patients with multiple injuries

• patients who would have been classified as ASA 3 status prior to their acute neurological event