Burn
Conditions
Brief summary
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.
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.
Interventions
DRUGFenofibrate
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
DRUGPlacebo
Placebo by mouth given daily throughout hospitalization for up to 12 months
DRUGPropranolol
Propranolol by mouth given daily throughout hospitalization for up to 12 months
Sponsors
National Institute of General Medical Sciences (NIGMS)
Shriners Hospitals for Children
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Metabolism | From randomization up to one year | Glucose levels and amount of regular insulin infused during hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypermetabolism | From randomization up to one year | Resting energy expenditure (REE) done weekly while in hospital |
| Rate pressure product | Participants will be followed for the duration of hospital stay, an average of 5 weeks | Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized |
Countries
United States
Outcome results
None listed