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NCT01712477 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function
A Phase 4 study, sponsored by Michigan State University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01712477 is a Phase 4 study that was terminated before completion, run by Michigan State University. The registered enrollment target is 1 participants.
The verdict
NCT01712477, a Phase 4 study, was terminated before completion, sponsored by Michigan State University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels. Sedation is part of the standard treatment in patients with a TBI and has been proposed as a neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam and propofol, are not standardized and it is unclear whether sedation has a significant impact on recovery and outcome. A review of propofol versus midazolam in mechanically ventilated patients shows evidence that both provide effective sedation but there is lack of data to support one sedative over the other. Cytokines are released in response to tissue injury and act to generate a variety of physiologic responses. The cytokine elevation has been correlated with the extent of tissue injury. This study will compare the cytokine distribution patterns at specific posttraumatic time points in patients with a TBI sedated with either propofol or midazolam. Additional analysis will compare the cytokine response in patients whom had elevated blood alcohol levels with those with normal levels. Neuropsychological testing will also be performed to determine the extent of brain injury and recovery.
Interventions
- DRUG Intravenous sedation using propofol
- DRUG Intravenous sedation with midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712477
The ClinicalTrials.gov registry entry for NCT01712477 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intravenous sedation using propofol is the first listed.
NCT01712477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01712477 about?
NCT01712477 is a clinical study titled "A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function". This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels. Sedation is part of the standard treatm...
What is the current status of trial NCT01712477?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2011-11. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01712477?
The interventions under investigation include: Intravenous sedation using propofol (DRUG), Intravenous sedation with midazolam (DRUG).
Who is sponsoring clinical trial NCT01712477?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
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