CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Rosuvastatin +1 moredrug
Likely dose
Rosuvastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00978419
NCT00978419Phase 2Completed

Randomized, Placebo Controlled, Pilot Trial of Statin Use in Burn Patients

Vanderbilt University Medical Center·interventional·Posted Sep 16, 2009·Updated Jun 1, 2018

In Brief

A Phase 2 clinical trial evaluating Rosuvastatin and Placebo for Burns. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2009
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.8 years ago

Interventions

Rosuvastatindrug

Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days

Placebodrug

Placebo administered every day for up to 28 days