Burns
Conditions
Keywords
anabolic agents, exercise
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 assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.
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 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.
Interventions
PROCEDUREStable Isotope Infusion Study
1-8 hour stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues.
PROCEDURECollection of blood and tissues
Blood draw with each stable isotope infusion study and weekly Tissue biopsy: skin, fat, muscle at stable isotope infusion study
PROCEDURERadiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI
Testing to be done following every stable isotope infusion study to measure muscle, fat and bone tissues.
DRUGHumatrope
Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.
DRUGKetoconazole
Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
DRUGOxandrolone
oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
DRUGPropranolol
Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
DRUGOxandrolone and propranolol combined
Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
DRUGHumatrope and propranolol combined
Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
DRUGPlacebo
placebo to be given once a day for up to two years post burn injury.
BEHAVIORALExercise--Hospital supervised intensive exercise program
intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.
BEHAVIORALHome exercise program
Home intensive exercise program: training occurs in hospital then patient sent home to continue exercise program for six weeks and up to 12 weeks at home.
Sponsors
U.S. Department of Education
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses. | Admission to burn unit and up to 2 years post burn and yearly after that | Dual Energy X-Ray Absorptiometry measurements will be utilized to measure muscle wasting |
Countries
United States
Outcome results
None listed