Fenofibrate and Propranolol in Burn Patients

Burn Clinical Trial

Official title:

Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients

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
• 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
• 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

Related Conditions & MeSH terms

• Burn
• Burns

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