Pilot Trial of Statin Use in Burn Patients (BURNSTAT)
|ClinicalTrials.gov Identifier: NCT00978419|
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : July 13, 2011
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.
- Statin administration within 96 hours of burn is safe, will decrease CRP, and will decrease septic shock and mortality in burn patients.
- The investigators hypothesize that burn patients will have a de-novo long term cognitive impairment at 3 months after burn.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: Rosuvastatin Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Placebo Controlled, Pilot Trial of Statin Use in Burn Patients|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: Rosuvastatin
Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days
Placebo Comparator: Placebo
Placebo administered every day for up to 28 days
- Primary endpoint: Reduction in CRP level over time, compared to placebo measured at baseline and days 3, 7, 14. The mean CRP levels at specified days will be the endpoints. [ Time Frame: Days 1, 3, 7, 14 ]
- mortality compared to placebo [ Time Frame: 90 days ]
- mortality compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 90 days ]
- Reduction in the incidence of septic shock (see definition) compared to placebo [ Time Frame: 28 days ]
- Reduction in the incidence of septic shock (see definition) compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 28 days ]
- A reduction in CK levels over time, compared to placebo measured at baseline and days 3, 7, 14, 21, 28 [ Time Frame: 28 days ]
- A reduction in ALT levels over time, compared to placebo, measured at baseline, days 1, 7, 14, 21, 28 [ Time Frame: 28 days ]
- Determine the safety of Rosuvastatin compared to placebo in burn patients by comparing the frequency, type and severity of adverse events [ Time Frame: 28 days ]
- Determine which are appropriate attainable endpoints for future trials and the number of participants required to reach significance in analysis of a variety of variables [ Time Frame: 28 days ]
- Determine the prevalence of delirium in the two subgroup of patients [ Time Frame: 28 days ]
- Determine the prevalence of de-novo long-term neurocognitive impairment in burn patients and by study group. [ Time Frame: 90 days ]
- Determine the prevalence of functional impairment in burn patients and by study group [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978419
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|