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

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Burns

Treatments: Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI; Behavioral: Home exercise program; Drug: Humatrope and propranolol combined; Drug: Humatrope; Drug: Placebo; Drug: Ketoconazole; Drug: Oxandrolone and propranolol combined; Procedure: Stable Isotope Infusion Study; Drug: Propranolol; Procedure: Collection of blood and tissues; Drug: Oxandrolone; Behavioral: Exercise--Hospital supervised intensive exercise program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00675714

NIDILRR 90DP0043-03-00

04-157

P50GM060338 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,126 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,126 participants in 9 patient groups, including a placebo group

1

Experimental group

Description:

Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Drug: Humatrope

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

2

Experimental group

Description:

Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Drug: Ketoconazole

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

3

Experimental group

Description:

Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Drug: Oxandrolone

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

4

Experimental group

Description:

Propranolol PO given daily throughout hospitalization for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

Drug: Propranolol

5

Experimental group

Description:

Oxandrolone and propranolol PO to be given daily for up to 2 years post burn

Treatment:

Drug: Oxandrolone and propranolol combined

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

6

Experimental group

Description:

Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Procedure: Stable Isotope Infusion Study

Drug: Humatrope and propranolol combined

Procedure: Collection of blood and tissues

7

Placebo Comparator group

Description:

Placebo PO to be given for up to 2 years post burn

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Drug: Placebo

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

8

Experimental group

Description:

Exercise--hospital supervised intensive exercise program

Treatment:

Behavioral: Exercise--Hospital supervised intensive exercise program

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

9

Experimental group

Description:

Exercise--home or community based exercise program

Treatment:

Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI

Procedure: Stable Isotope Infusion Study

Procedure: Collection of blood and tissues

Behavioral: Home exercise program