Fenofibrate and Propranolol in Burn Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients

Conditions
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Burn

Intervention / Treatment
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* Drug: Fenofibrate
* Drug: Placebo
* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fenofibrate<br>Fenofibrate by mouth given daily throughout hospitalization for up to 12 months | Drug: Fenofibrate<br>* Fenofibrate by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: Tricor;|
| Active Comparator: Fenofibrate and Propranolol<br>Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months | Drug: Fenofibrate<br>* Fenofibrate by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: Tricor;Drug: Propranolol<br>* Propranolol by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: inderal;|
| Placebo Comparator: Placebo<br>Placebo by mouth given daily throughout hospitalization for up to 12 months. | Drug: Placebo<br>* Placebo by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: Control;|
| Active Comparator: Propranolol<br>Propranolol by mouth given throughout hospitalization for up to 12 months | Drug: Propranolol<br>* Propranolol by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: inderal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Metabolism | Glucose levels and amount of regular insulin infused during hospitalization. | From randomization up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypermetabolism | Resting energy expenditure (REE) done weekly while in hospital | From randomization up to one year | 
| Rate pressure product | Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized | Participants will be followed for the duration of hospital stay, an average of 5 weeks |