Status:
COMPLETED
Pilot Trial of Statin Use in Burn Patients
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pro...
Detailed Description
Infection and sepsis are the major causes of morbidity and mortality in burn patients. Several observational studies have shown that HMG-CoA reductase inhibitors, known as statins, before or after ill...
Eligibility Criteria
Inclusion
- Thermal burn occurring within the 96 hours prior to dosing
Exclusion
- Inability to obtain informed consent (or assent from surrogate)
- Less than 18 years of age
- Patient or surrogate not committed and/or not likely to remain committed to full support, as, for example, would be the case for a patient with end-stage cancer or other end-stage terminal conditions. Commitment to full support need not include cardiopulmonary resuscitation provided the team is committed to other forms of full support
- Unable to receive or absorb enteral study drug
- Statin specific exclusions
- Receiving a statin medication within 48 hours of dosing (to exclude controls from exposure to statins)
- Allergy or intolerance to statins
- ALT or AST \> 5 times upper limit of normal
- Untreated hypothyroidism by history (package insert)
- Pregnancy or breastfeeding
- Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or oral contraceptives within 24 hours prior to admission (package insert)
- Advanced cirrhosis, defined as a history of chronic liver disease and a Child-Pugh Class score \>10 (Appendix A)
- Moribund patient not expected to survive 24 hours
- Patients admitted to the Burn Service for non-thermal burn conditions, including chemical burn, TENS, electrical injury or wound care
- Patient expected to be discharged within 24 hours
- Patients of Asian descent (due to pharmacokinetics issues with Rosuvastatin in this population)
- Patients receiving another interventional investigational drug within the 30 days prior to dosing
- Patients otherwise unsuitable for participation in the opinion of the investigator.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00978419
Start Date
March 1 2010
End Date
May 1 2011
Last Update
June 1 2018
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232