Burn Clinical Trial
Official title:
Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
Verified date | August 2018 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Shriners Hospitals for Children | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | National Institute of General Medical Sciences (NIGMS), Shriners Hospitals for Children |
United States,
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 |
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