Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 80
Updated:6/18/2016
Start Date:January 2004
End Date:September 2017
Contact:David N Herndon, MD
Email:dherndon@utmb.edu
Phone:409-770-6731

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Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

The purpose of the program is to study and characterize the outcome of burn injury with
particular attention to improving the rehabilitation of burn survivors, including children.
Various agents are assessed for effectiveness on long term burn outcome, such as growth
hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.

The University of Texas Medical Branch(UTMB) project improves outcomes for severely burned
children by instituting and evaluating two modifications to traditional rehabilitation: (1)
an intensive rehabilitation program including active resistance exercise; (2) long term
administration of anabolic agents.

Effectiveness is assessed by comparison with functional outcomes achieved in traditional
outpatient rehabilitation programs. Results indicate improvement in strength, endurance and
bone density with these modifications. The project also maintains a longitudinal database
that includes measures of cardiopulmonary function, growth and maturation, bone density,
range of motion, and psychosocial adjustment.

Inclusion Criteria:

- Burn 30% Total Body Surface Area (TBSA) or greater

- Ages 0-80 yrs

- Negative pregnancy test

- Informed consent

Exclusion Criteria:

- Untreated malignancy, known history of AIDS, ARC, HIV

- Recent history of myocardial infarction (6 wks)

- Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases,
autoimmune diseases

- Chronic glucocorticoid or non steroidal anti inflammatory drug therapy

- Diabetes mellitus prior to burn injury

- Renal insufficiency (defined by creatinine >3.0 mg/dl)

- Hepatic disease (bilirubin > 3.0 mg/dl)
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: David N Herndon, MD
Phone: 409-770-6731
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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from
Galveston, TX
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