Fenofibrate and Propranolol in Burn Patients

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Burn

Treatments: Drug: Placebo; Drug: Propranolol; Drug: Fenofibrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02452255

14-0441

NIH RO1GM056687 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 4 patient groups, including a placebo group

Fenofibrate

Active Comparator group

Description:

Fenofibrate by mouth given daily throughout hospitalization for up to 12 months

Treatment:

Drug: Fenofibrate

Fenofibrate and Propranolol

Active Comparator group

Description:

Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months

Treatment:

Drug: Fenofibrate

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

Placebo by mouth given daily throughout hospitalization for up to 12 months.

Treatment:

Drug: Placebo

Propranolol

Active Comparator group

Description:

Propranolol by mouth given throughout hospitalization for up to 12 months

Treatment:

Drug: Propranolol