NCT00675714

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,126 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burns

Interventions

Type	Name	Description
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.
PROCEDURE	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
PROCEDURE	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.
DRUG	Ketoconazole	Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
DRUG	Oxandrolone	oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
DRUG	Propranolol	Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
DRUG	Oxandrolone and propranolol combined	Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
DRUG	Humatrope and propranolol combined	Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
DRUG	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.
BEHAVIORAL	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.

Timeline

• Start date: 2004-01-01
• Primary completion: 2018-09-01
• Completion: 2019-07-15
• First posted: 2008-05-12
• Last updated: 2019-11-29

Locations

1 site across 1 country: United States