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Fenofibrate and Propranolol in Burn Patients

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Terminated
CT.gov ID
NCT02452255
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH), Shriners Hospitals for Children (Other)
18
Enrollment
1
Location
4
Arms
44.3
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Jul 12, 2019

Arms and Interventions

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: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glucose Metabolism [From randomization up to one year]

      Glucose levels and amount of regular insulin infused during hospitalization.

    Secondary Outcome Measures

    1. Hypermetabolism [From randomization up to one year]

      Resting energy expenditure (REE) done weekly while in hospital

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 80 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shriners Hospitals for Children Galveston Texas United States 77551

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: David N Herndon, MD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Medical Branch, Galveston
    ClinicalTrials.gov Identifier:
    NCT02452255
    Other Study ID Numbers:
    • 14-0441
    • NIH RO1GM056687
    First Posted:
    May 22, 2015
    Last Update Posted:
    Nov 29, 2019
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Burns
    Propranolol
    Metoprolol
    Fenofibrate

    Study Results

    No Results Posted as of Nov 29, 2019