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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: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT00978419 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00978419 record still lists
NCT00978419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00978419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00978419's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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