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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 is a Phase 4 study that was terminated before completion, run by University of Louisville. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01137773
The ClinicalTrials.gov registry entry for NCT01137773 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Insulin is the first listed.
NCT01137773 reports 0 study locations.
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.
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