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NCT00978419 · ClinicalTrials.gov registry record · Phase 2
Pilot Trial of Statin Use in Burn Patients
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00978419 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT00978419, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to 28 days. The study will assess the affect of statins administered soon after burn injury on C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The investigators also seek to describe the correlation between exposure to statins and development of delirium and de-novo long-term cognitive impairment. Hypothesis: 1. Statin administration within 96 hours of burn is safe, will decrease CRP, and will decrease septic shock and mortality in burn patients. 2. The investigators hypothesize that burn patients will have a de-novo long term cognitive impairment at 3 months after burn. 3. The investigators hypothesize the use of statins in burn patients will reduce the development and the degree of cognitive impairment at 3 months post burn.
Interventions
- DRUG Placebo
- DRUG Rosuvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00978419
The ClinicalTrials.gov registry entry for NCT00978419 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00978419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00978419 about?
NCT00978419 is a clinical study titled "Pilot Trial of Statin Use in Burn Patients". This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to 28 days. The study will assess the affect of statins administered soon after burn injury on C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The investigators also seek ...
What is the current status of trial NCT00978419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-03. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00978419?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT00978419?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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