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

• Status: Terminated
• Trial end date: 2019-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH); Shriners Hospitals for Children; U.S. Department of Education
• Treatments: Anabolic Agents; Fluconazole; Hormones; Hydroxyitraconazole; Itraconazole; Ketoconazole; Methyltestosterone; Metoprolol; Nandrolone; Nandrolone Decanoate; Nandrolone phenpropionate; Oxandrolone; Propranolol; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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, Aids Related Complex, 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)