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NCT01137773 · ClinicalTrials.gov registry record · Phase 4
Normoglycemia and Neurological Outcome
A Phase 4 study, sponsored by University of Louisville.
- Terminated
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT01137773: Clinical Trial Phase 4 study, sponsored by University of Louisville.
NCT01137773 is a Phase 4 study that was terminated before completion, run by University of Louisville. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01137773, a Phase 4 study, was terminated before completion, sponsored by University of Louisville.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions: Normal no complaints; no evidence of disease - 100. Normal activity with effort; some signs or symptoms of disease -
Interventions
- DRUG Insulin
- DRUG Conventional insulin treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2007-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
Why NCT01137773 stopped before completion
NCT01137773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin is the first listed.
NCT01137773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01137773 about?
NCT01137773 is a clinical study titled "Normoglycemia and Neurological Outcome". 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 neurol...
What is the current status of trial NCT01137773?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2007-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01137773?
The interventions under investigation include: Insulin (DRUG), Conventional insulin treatment (DRUG).
Who is sponsoring clinical trial NCT01137773?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01137773's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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