University of Texas Medical Branch

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

Purpose

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.

Condition

Burns

Eligibility

Eligible Ages: Under 80 Years
Eligible Genders: All
Accepts 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)

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 1	Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn	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. Other names: recombinant human growth hormone Growth Hormone
Experimental 2	Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn	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: Ketoconazole Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury Other names: itraconazole fluconazole
Experimental 3	Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn	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: Oxandrolone oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury Other names: testosterone nandrolone
Experimental 4	Propranolol PO given daily throughout hospitalization for up to 2 years post burn	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: Propranolol Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury. Other names: metoprolol inderol
Experimental 5	Oxandrolone and propranolol PO to be given daily for up to 2 years post burn	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: Oxandrolone and propranolol combined Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury. Other names: testosterone nandrolone inderol metoprolol
Experimental 6	Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn	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 and propranolol combined Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury. Other names: recombinant human growth hormone Growth Hormone inderol metoprolol
Placebo Comparator 7	Placebo PO to be given for up to 2 years post burn	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: Placebo placebo to be given once a day for up to two years post burn injury. Other names: control
Experimental 8	Exercise--hospital supervised intensive exercise program	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. 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. Other names: exercise intensive exercise aerobic exercise exercise rehabilitation program hospital based exercise
Experimental 9	Exercise--home or community based exercise program	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. 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. Other names: Home exercise intensive exercise exercise rehabilitation

More Details

Status: Terminated
Sponsor: The University of Texas Medical Branch, Galveston

Study Contact

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.

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