Status:
TERMINATED
Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
U.S. Department of Education
National Institutes of Health (NIH)
Conditions:
Burns
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE2
PHASE3
Brief 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 a...
Detailed Description
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 reha...
Eligibility Criteria
Inclusion
- Burn 30% Total Body Surface Area (TBSA) or greater
- Ages 0-80 yrs
- Negative pregnancy test
- Informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
1126 Patients enrolled
Trial Details
Trial ID
NCT00675714
Start Date
January 1 2004
End Date
July 15 2019
Last Update
November 29 2019
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77551