Fenofibrate and Propranolol in Burn Patients

Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients

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.

Study Overview

• Status: Terminated
• Conditions: Burn
• Intervention / Treatment: Drug: Propranolol; Drug: Fenofibrate; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77551
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fenofibrate; Fenofibrate by mouth given daily throughout hospitalization for up to 12 months	Drug: Fenofibrate; Fenofibrate by mouth given daily throughout hospitalization for up to 12 months; Other Names: Tricor
Active Comparator: Fenofibrate and Propranolol; Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months	Drug: Propranolol; Propranolol by mouth given daily throughout hospitalization for up to 12 months; Other Names: Metoprolol; inderal; Drug: Fenofibrate; Fenofibrate by mouth given daily throughout hospitalization for up to 12 months; Other Names: Tricor
Placebo Comparator: Placebo; Placebo by mouth given daily throughout hospitalization for up to 12 months.	Drug: Placebo; Placebo by mouth given daily throughout hospitalization for up to 12 months; Other Names: Control
Active Comparator: Propranolol; Propranolol by mouth given throughout hospitalization for up to 12 months	Drug: Propranolol; Propranolol by mouth given daily throughout hospitalization for up to 12 months; Other Names: Metoprolol; inderal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute of General Medical Sciences (NIGMS); Shriners Hospitals for Children

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): July 12, 2019

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Propranolol; Fenofibrate; Metoprolol
• Other Study ID Numbers: 14-0441; NIH RO1GM056687 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO