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Fenofibrate and Propranolol in Burn Patients

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ClinicalTrials.gov Identifier: NCT02452255
Recruitment Status : Recruiting
First Posted : May 22, 2015
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
Shriners Hospitals for Children
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Burn Drug: Fenofibrate Drug: Placebo Drug: Propranolol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 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 : November 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Glucose Metabolism [ Time Frame: From randomization up to one year ]
    Glucose levels and amount of regular insulin infused during hospitalization.


Secondary Outcome Measures :
  1. Hypermetabolism [ Time Frame: From randomization up to one year ]
    Resting energy expenditure (REE) done weekly while in hospital

  2. Rate pressure product [ Time Frame: 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



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452255


Contacts
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Contact: Catherine Reed, RN 409-771-6987 ca2reed@utmb.edu
Contact: Deb Benjamin, RN 409-770-6731 dbenjami@utmb.edu

Locations
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United States, Texas
Shriners Hospitals for Children Recruiting
Galveston, Texas, United States, 77551
Contact: Cathy Reed, BSN    409-770-6987    ca2reed@utmb.edu   
Contact: Deb Benjamin, MSN    409-770-6731    dbenjami@utmb.edu   
Principal Investigator: David N Herndon, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Institute of General Medical Sciences (NIGMS)
Shriners Hospitals for Children
Investigators
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Principal Investigator: David N Herndon, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02452255     History of Changes
Other Study ID Numbers: 14-0441
NIH RO1GM056687 ( Other Grant/Funding Number: NIH )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Propranolol
Burns
Wounds and Injuries
Fenofibrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents