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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00675714
• Other study ID #: 04-157
• Secondary ID: NIDILRR 90DP0043
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 2004
• Est. completion date: July 15, 2019

Study information

• Verified date: August 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1126
• Est. completion date: July 15, 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Stable 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.
• Collection of blood and tissues
Blood draw with each stable isotope infusion study and weekly Tissue biopsy: skin, fat, muscle at stable isotope infusion study
• Radiology 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.

Drug:
• Humatrope
Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.
• Ketoconazole
Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
• Oxandrolone
oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
• Propranolol
Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
• Oxandrolone and propranolol combined
Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
• Humatrope and propranolol combined
Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
• Placebo
placebo to be given once a day for up to two years post burn injury.

Behavioral:
• Exercise--Hospital supervised intensive exercise program
intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.
• Home 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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

Alloju SM, Herndon DN, McEntire SJ, Suman OE. Assessment of muscle function in severely burned children. Burns. 2008 Jun;34(4):452-9. doi: 10.1016/j.burns.2007.10.006. Epub 2008 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.	Dual Energy X-Ray Absorptiometry measurements will be utilized to measure muscle wasting	Admission to burn unit and up to 2 years post burn and yearly after that

External Links

•   burn care web site includes information on funded grant project
•   University of Texas web page to describe funded program