Fenofibrate and Propranolol in Burn Patients

Phase 2

Terminated

• Conditions: Burn
• Interventions: Drug: Fenofibrate; Drug: Placebo; Drug: Propranolol

• Registration Number: NCT02452255
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-22
• Study Start: 2015-11
• Status Verified: 2018-08
• Primary Completion: 2018-12
• Study Completion: 2019-07-12
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenofibrate	Fenofibrate	Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
Fenofibrate and Propranolol	Fenofibrate	Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months
Fenofibrate and Propranolol	Propranolol	Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months
Placebo	Placebo	Placebo by mouth given daily throughout hospitalization for up to 12 months.
Propranolol	Propranolol	Propranolol by mouth given throughout hospitalization for up to 12 months

Primary Outcome Measures

Name	Time	Method
Glucose Metabolism	From randomization up to one year	Glucose levels and amount of regular insulin infused during hospitalization.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Galveston, Texas, United States