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

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.

Conditions

• Burns

Interventions

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.

Sponsors & Collaborators

• U.S. Department of Education

  collaborator FED

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• The University of Texas Medical Branch, Galveston

  lead OTHER

Principal Investigators

• David N Herndon, MD · University of Texas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2018-09-30

Completion

2019-07-15

Countries

• United States

Study Locations