Fenofibrate and Propranolol in Burn Patients
Purpose
The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.
Condition
- Burn
Eligibility
- Eligible Ages
- Under 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 0 through 80 years - ≥ 20% Total Body Surface Area Burn injury
Exclusion Criteria
Pregnancy History or existence of pre-burn injury conditions - Allergies to propranolol or fenofibrate - Asthma requiring treatment - Congestive heart failure (measured ejection fraction < 20%) - Renal or hepatic disease - Medical condition requiring glucocorticoid treatment - History of AIDS, Aids Related Complex or HIV - History of Cancer within 5 years Decision not to treat due to burn injury severity or futility as deemed by the clinical team
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Fenofibrate |
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months |
|
Active Comparator Fenofibrate and Propranolol |
Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months |
|
Placebo Comparator Placebo |
Placebo by mouth given daily throughout hospitalization for up to 12 months. |
|
Active Comparator Propranolol |
Propranolol by mouth given throughout hospitalization for up to 12 months |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
Detailed Description
Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.