Pilot Trial of Statin Use in Burn Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT00978419

Run by

Vanderbilt University Medical Center

People needed

40

Starts

2010-03-01

Expected to finish

2011-05-01

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Thermal burn occurring within the 96 hours prior to dosing

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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