Fenofibrate and Propranolol in Burn Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-07-12

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.

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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.

Conditions

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Burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fenofibrate

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

Group Type ACTIVE_COMPARATOR

Fenofibrate

Intervention Type DRUG

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

Fenofibrate and Propranolol

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

Group Type ACTIVE_COMPARATOR

Fenofibrate

Intervention Type DRUG

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

Propranolol

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Propranolol

Propranolol by mouth given throughout hospitalization for up to 12 months

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

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

Interventions

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Fenofibrate

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Propranolol

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

Intervention Type DRUG

Other Intervention Names

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Tricor Control Metoprolol inderal

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

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No