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Fenofibrate and Propranolol in Burn Patients

Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burn

Intervention: Fenofibrate (Drug); Placebo (Drug); Propranolol (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
David N Herndon, MD, Principal Investigator, Affiliation: University of Texas

Overall contact:
Catherine Reed, RN, Phone: 409-771-6987, Email: ca2reed@utmb.edu

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.

Clinical Details

Official title: Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Glucose Metabolism

Secondary outcome:

Hypermetabolism

Rate pressure product

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.

Eligibility

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 0 through 80 years

- ≥ 20% TBSA 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, ARC 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

Locations and Contacts

Catherine Reed, RN, Phone: 409-771-6987, Email: ca2reed@utmb.edu

Shriners Hospitals for Children, Galveston, Texas 77551, United States
Additional Information

Starting date: June 2015
Last updated: May 22, 2015

Page last updated: August 23, 2015

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