Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
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ClinicalTrials.gov Identifier: NCT00675714 |
Recruitment Status
:
Recruiting
First Posted
: May 12, 2008
Last Update Posted
: May 31, 2017
|
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Condition or disease | Intervention/treatment | 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 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | January 2004 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | September 2018 |
Arm | Intervention/treatment |
---|---|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
- 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 ]

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Ages Eligible for Study: | up to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675714
Contact: David N Herndon, MD | 409-770-6731 | dherndon@utmb.edu | |
Contact: Cathy L Reed, BSN | 409-770-6987 | ca2reed@utmb.edu |
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 |
Study Director: | David N Herndon, MD | University of Texas |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The University of Texas Medical Branch, Galveston |
ClinicalTrials.gov Identifier: | NCT00675714 History of Changes |
Other Study ID Numbers: |
04-157 NIDILRR 90DP0043-03-00 P50GM060338 ( U.S. NIH Grant/Contract ) |
First Posted: | May 12, 2008 Key Record Dates |
Last Update Posted: | May 31, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by The University of Texas Medical Branch, Galveston:
anabolic agents exercise |
Additional relevant MeSH terms:
Hormones Testosterone Methyltestosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Oxandrolone Nandrolone Nandrolone decanoate Nandrolone phenpropionate Itraconazole Ketoconazole Fluconazole Anabolic Agents Propranolol |
Metoprolol Hydroxyitraconazole Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Androgens Antineoplastic Agents, Hormonal Antineoplastic Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents |