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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02452255
Other study ID # 14-0441
Secondary ID NIH RO1GM056687
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date November 2015
Est. completion date July 12, 2019

Study information

Verified date August 2018
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date July 12, 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Fenofibrate
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
Placebo
Placebo by mouth given daily throughout hospitalization for up to 12 months
Propranolol
Propranolol by mouth given daily throughout hospitalization for up to 12 months

Locations

Country Name City State
United States Shriners Hospitals for Children Galveston Texas

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose Metabolism Glucose levels and amount of regular insulin infused during hospitalization. From randomization up to one year
Secondary Hypermetabolism Resting energy expenditure (REE) done weekly while in hospital From randomization up to one year
Secondary 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
See also
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Completed NCT04516148 - A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting Phase 4
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Completed NCT02394873 - A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound Phase 1
Completed NCT00239668 - Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Completed NCT04781348 - Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale Phase 4