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

Condition(s) targeted: Burns

Intervention: Stable Isotope Infusion Study (Procedure); Collection of blood and tissues (Procedure); Radiology testing: DEXA, K+ counter, ultrasound, MRI (Procedure); Humatrope (Drug); Ketoconazole (Drug); Oxandrolone (Drug); Propranolol (Drug); Oxandrolone and propranolol combined (Drug); Humatrope and propranolol combined (Drug); Placebo (Drug); Exercise--Hospital supervised intensive exercise program (Behavioral); Home exercise program (Behavioral)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: The University of Texas, Galveston

Official(s) and/or principal investigator(s):
David N Herndon, MD, Study Director, Affiliation: University of Texas

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

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.

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

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

Primary outcome: 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.

Detailed description: 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.

Minimum age: N/A. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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)

David N Herndon, MD, Phone: 409-770-6731, Email: dherndon@utmb.edu

University of Texas Medical Branch, Galveston, Texas 77551, United States; Recruiting
David N Herndon, MD, Phone: 409-770-6731, Email: dherndon@utmb.edu
Deb A Benjamin, MSN, Phone: 409-770-6731, Email: dbenjami@utmb.edu
David N Herndon, MD, Principal Investigator
Oscar E Suman, PhD, Sub-Investigator
Marc G Jeschke, MD, PhD, Sub-Investigator

University of Texas web page to describe funded program

burn care web site includes information on funded grant project

Related publications:

Alloju SM, Herndon DN, McEntire SJ, Suman OE. Assessment of muscle function in severely burned children. Burns. 2008 Jun;34(4):452-9. Epub 2008 Feb 20.

Starting date: January 1998
Ending date: September 2010
Last updated: May 7, 2009