Purpose

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.

Condition

Eligibility

Eligible Ages
Under 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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: Fenofibrate
    Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
    Other names:
    • Tricor
  • Drug: Propranolol
    Propranolol by mouth given daily throughout hospitalization for up to 12 months
    Other names:
    • Metoprolol
    • inderal
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

Recruiting Locations

Shriners Hospitals for Children
Galveston, Texas 77551
Contact:
Cathy Reed, BSN
409-770-6987
ca2reed@utmb.edu

More Details

NCT ID
NCT02452255
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Catherine Reed, RN
409-771-6987
ca2reed@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.