Official Title: “Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation”

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, insulin, ketoconazole, inhospital exercise and home exercise.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2010

The 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.

Intervention(s) in this Clinical Trial

• 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: DEXA, K+ counter, 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 2 years post burn injury.
• Drug: Ketoconazole
  • Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for 2 years post burn injury
• Drug: Oxandrolone
  • oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for 2 years post burn injury
• Drug: Propranolol
  • Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for 2 years post burn injury.
• Drug: Oxandrolone and propranolol combined
  • Daily administration of oxandrolone and propranolol to be given for 2 years post burn injury.
• Drug: Humatrope and propranolol combined
  • Humatrope (growth hormone) and propranolol administration daily for 2 years post burn injury.
• Drug: Placebo
  • placebo to be given once a day for two years post burn injury.
• Behavioral: Exercise--Hospital supervised intensive exercise program
  • intensive exercise program supervised by trained personnel in the hospital environment for twelve week program.
• Behavioral: Home exercise program
  • Home intensive exercise program: training occurs in hospital then patient sent home to continue exercise program for 12 weeks at home.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Humatrope SQ 0.05-0.2 mg/kg/day for 2 years post burn
• Experimental: 2
  • Ketoconazole PO given twice a day throughout hospitalization until 2 years post burn
• Experimental: 3
  • Oxandrolone PO given daily throughout hospitalization until 2 years post burn
• Experimental: 4
  • Propranolol PO given daily throughout hospitalization until 2 years post burn
• Experimental: 5
  • Oxandrolone and propranolol PO to be given daily until 2 years post burn
• Experimental: 6
  • Humatrope SQ and Propranolol PO to be given daily 2 years post burn
• Placebo Comparator: 7
  • Placebo PO to be given until 2 years post burn
• Experimental: 8
  • Exercise--hospital supervised intensive exercise program
• Experimental: 9
  • Exercise--home exercise program

Primary Measures

• Outcome assessments will include measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.
  • Time Frame: Admission to burn unit to 95% wound healing
    Safety Issue?: No

Inclusion Criteria:

• Burn 40% TBSA or greater
• Ages 0-65 yrs
• Negative pregnancy test
• Informed consent

Exclusion Criteria:

• Untreated malignancy, known history of AIDS, ARC, 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The University of Texas, Galveston

Overall Clinical Trial Officials and Contacts

David N Herndon, MD Study Director University of Texas  

Overall Contact: David N Herndon, MD 409-770-6731 dherndon@utmb.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675714

Study ID Number: 04-157

ClinicalTrials.gov Identifier: NCT00675714

Health Authority: United States: Food and Drug Administration

University of Texas web page to describe funded program

burn care web site includes information on funded grant project