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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborators:
U.S. Department of Education
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00675714
First received: December 26, 2007
Last updated: June 23, 2014
Last verified: June 2014
  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 Intervention Phase
Burns
Procedure: Stable Isotope Infusion Study
Procedure: Collection of blood and tissues
Procedure: Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI
Drug: Humatrope
Drug: Ketoconazole
Drug: Oxandrolone
Drug: Propranolol
Drug: Oxandrolone and propranolol combined
Drug: Humatrope and propranolol combined
Drug: Placebo
Behavioral: Exercise--Hospital supervised intensive exercise program
Behavioral: Home exercise program
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome 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 and up to 2 years post burn and yearly after that ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2004
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • GH
  • rhGH
  • 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:
  • metroprolol
  • 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
  • GH
  • rhGH
  • inderol
  • metoprolol
  • growth hormone
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675714

Contacts
Contact: David N Herndon, MD 409-770-6731 dherndon@utmb.edu
Contact: Cathy L Reed, BSN 409-770-6987 ca2reed@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77551
Contact: David N Herndon, MD    409-770-6731    dherndon@utmb.edu   
Contact: Cathy L Reed, BSN    409-770-6987    ca2reed@utmb.edu   
Principal Investigator: David N Herndon, MD         
Sub-Investigator: Oscar E Suman, PhD         
Sub-Investigator: Celeste FInnerty, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
U.S. Department of Education
Shriners Hospitals for Children
Investigators
Study Director: David N Herndon, MD University of Texas
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00675714     History of Changes
Other Study ID Numbers: 04-157, NIDRR H133A020102, NIH P50 GM60338, SHC #8760
Study First Received: December 26, 2007
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
anabolic agents
exercise

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Nandrolone
Oxandrolone
Methyltestosterone
Hormones
Nandrolone decanoate
Nandrolone phenpropionate
Anabolic Agents
Metoprolol
Propranolol
Metoprolol succinate
Fluconazole
Ketoconazole
Itraconazole
Hydroxyitraconazole
Androgens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on July 23, 2014