MedTrace Logo

Normoglycemia and Neurological Outcome

NCT01137773 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-01-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Acute, Non-traumatic Subarachnoid Hemorrhage
  • Intraparenchymal Hemorrhage
  • Brain Injuries

Interventions

DRUG

Insulin

All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.

DRUG

Conventional insulin treatment

All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Rainer Lenhardt, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137773 on ClinicalTrials.gov