Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
NCT ID: NCT00675714
Last Updated: 2019-11-29
Study Results
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Basic Information
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TERMINATED
PHASE2/PHASE3
1126 participants
INTERVENTIONAL
2004-01-31
2019-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
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.
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
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.
Humatrope
Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.
2
Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
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.
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
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.
Ketoconazole
Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
3
Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
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.
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
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.
Oxandrolone
oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
4
Propranolol PO given daily throughout hospitalization for up to 2 years post burn
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.
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
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.
Propranolol
Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
5
Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
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.
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
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.
Oxandrolone and propranolol combined
Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
6
Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
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.
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
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.
Humatrope and propranolol combined
Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
7
Placebo PO to be given for up to 2 years post burn
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.
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
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.
Placebo
placebo to be given once a day for up to two years post burn injury.
8
Exercise--hospital supervised intensive exercise program
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.
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
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.
Exercise--Hospital supervised intensive exercise program
intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.
9
Exercise--home or community based exercise program
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.
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
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.
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.
Interventions
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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.
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
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.
Humatrope
Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.
Ketoconazole
Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
Oxandrolone
oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
Propranolol
Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
Oxandrolone and propranolol combined
Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
Humatrope and propranolol combined
Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
Placebo
placebo to be given once a day for up to two years post burn injury.
Exercise--Hospital supervised intensive exercise program
intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 0-80 yrs
* Negative pregnancy test
* Informed consent
Exclusion Criteria
* 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)
80 Years
ALL
No
Sponsors
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U.S. Department of Education
FED
National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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David N Herndon, MD
Role: STUDY_DIRECTOR
University of Texas
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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References
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Alloju SM, Herndon DN, McEntire SJ, Suman OE. Assessment of muscle function in severely burned children. Burns. 2008 Jun;34(4):452-9. doi: 10.1016/j.burns.2007.10.006. Epub 2008 Feb 20.
Guillory AN, Herndon DN, Silva MB 3rd, Andersen CR, Suman OE, Finnerty CC. Oxandrolone Coadministration Does Not Alter Plasma Propranolol Concentrations in Severely Burned Pediatric Patients. J Burn Care Res. 2017 Jul/Aug;38(4):243-250. doi: 10.1097/BCR.0000000000000494.
Herndon DN, Voigt CD, Capek KD, Wurzer P, Guillory A, Kline A, Andersen CR, Klein GL, Tompkins RG, Suman OE, Finnerty CC, Meyer WJ, Sousse LE. Reversal of Growth Arrest With the Combined Administration of Oxandrolone and Propranolol in Severely Burned Children. Ann Surg. 2016 Sep;264(3):421-8. doi: 10.1097/SLA.0000000000001844.
Sousse LE, Herndon DN, Mlcak RP, Lee JO, Andersen CR, Zovath AJ, Finnerty CC, Suman OE. Long-Term Administration of Oxandrolone Improves Lung Function in Pediatric Burned Patients. J Burn Care Res. 2016 Sep-Oct;37(5):273-7. doi: 10.1097/BCR.0000000000000356.
Diaz EC, Herndon DN, Lee J, Porter C, Cotter M, Suman OE, Sidossis LS, Borsheim E. Predictors of muscle protein synthesis after severe pediatric burns. J Trauma Acute Care Surg. 2015 Apr;78(4):816-22. doi: 10.1097/TA.0000000000000594.
Kraft R, Herndon DN, Finnerty CC, Cox RA, Song J, Jeschke MG. Predictive Value of IL-8 for Sepsis and Severe Infections After Burn Injury: A Clinical Study. Shock. 2015 Mar;43(3):222-7. doi: 10.1097/SHK.0000000000000294.
Patel P, Sallam HS, Ali A, Chandalia M, Suman O, Finnerty CC, Herndon DN, Abate N. Changes in fat distribution in children following severe burn injury. Metab Syndr Relat Disord. 2014 Dec;12(10):523-6. doi: 10.1089/met.2014.0098. Epub 2014 Sep 11.
Chondronikola M, Meyer WJ, Sidossis LS, Ojeda S, Huddleston J, Stevens P, Borsheim E, Suman OE, Finnerty CC, Herndon DN. Predictors of insulin resistance in pediatric burn injury survivors 24 to 36 months postburn. J Burn Care Res. 2014 Sep-Oct;35(5):409-15. doi: 10.1097/BCR.0000000000000017.
Hardee JP, Porter C, Sidossis LS, Borsheim E, Carson JA, Herndon DN, Suman OE. Early rehabilitative exercise training in the recovery from pediatric burn. Med Sci Sports Exerc. 2014 Sep;46(9):1710-6. doi: 10.1249/MSS.0000000000000296.
Finnerty CC, Ali A, McLean J, Benjamin N, Clayton RP, Andersen CR, Mlcak RP, Suman OE, Meyer W, Herndon DN. Impact of stress-induced diabetes on outcomes in severely burned children. J Am Coll Surg. 2014 Apr;218(4):783-95. doi: 10.1016/j.jamcollsurg.2014.01.038. Epub 2014 Jan 24.
Finnerty CC, Herndon DN. Is propranolol of benefit in pediatric burn patients? Adv Surg. 2013;47:177-97. doi: 10.1016/j.yasu.2013.02.001. No abstract available.
Finnerty CC, Mabvuure NT, Ali A, Kozar RA, Herndon DN. The surgically induced stress response. JPEN J Parenter Enteral Nutr. 2013 Sep;37(5 Suppl):21S-9S. doi: 10.1177/0148607113496117.
Ray S, Ju X, Sun H, Finnerty CC, Herndon DN, Brasier AR. The IL-6 trans-signaling-STAT3 pathway mediates ECM and cellular proliferation in fibroblasts from hypertrophic scar. J Invest Dermatol. 2013 May;133(5):1212-20. doi: 10.1038/jid.2012.499. Epub 2013 Jan 10.
Kraft R, Herndon DN, Finnerty CC, Hiyama Y, Jeschke MG. Association of postburn fatty acids and triglycerides with clinical outcome in severely burned children. J Clin Endocrinol Metab. 2013 Jan;98(1):314-21. doi: 10.1210/jc.2012-2599. Epub 2012 Nov 12.
Herndon DN, Rodriguez NA, Diaz EC, Hegde S, Jennings K, Mlcak RP, Suri JS, Lee JO, Williams FN, Meyer W, Suman OE, Barrow RE, Jeschke MG, Finnerty CC. Long-term propranolol use in severely burned pediatric patients: a randomized controlled study. Ann Surg. 2012 Sep;256(3):402-11. doi: 10.1097/SLA.0b013e318265427e.
Jeschke MG, Williams FN, Finnerty CC, Rodriguez NA, Kulp GA, Ferrando A, Norbury WB, Suman OE, Kraft R, Branski LK, Al-mousawi AM, Herndon DN. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes. PLoS One. 2012;7(5):e35465. doi: 10.1371/journal.pone.0035465. Epub 2012 May 11.
Porro LJ, Herndon DN, Rodriguez NA, Jennings K, Klein GL, Mlcak RP, Meyer WJ, Lee JO, Suman OE, Finnerty CC. Five-year outcomes after oxandrolone administration in severely burned children: a randomized clinical trial of safety and efficacy. J Am Coll Surg. 2012 Apr;214(4):489-502; discussion 502-4. doi: 10.1016/j.jamcollsurg.2011.12.038.
Traber MG, Leonard SW, Traber DL, Traber LD, Gallagher J, Bobe G, Jeschke MG, Finnerty CC, Herndon D. alpha-Tocopherol adipose tissue stores are depleted after burn injury in pediatric patients. Am J Clin Nutr. 2010 Dec;92(6):1378-84. doi: 10.3945/ajcn.2010.30017. Epub 2010 Sep 29.
Branski LK, Herndon DN, Barrow RE, Kulp GA, Klein GL, Suman OE, Przkora R, Meyer W 3rd, Huang T, Lee JO, Chinkes DL, Mlcak RP, Jeschke MG. Randomized controlled trial to determine the efficacy of long-term growth hormone treatment in severely burned children. Ann Surg. 2009 Oct;250(4):514-23. doi: 10.1097/SLA.0b013e3181b8f9ca.
Related Links
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University of Texas web page to describe funded program
burn care web site includes information on funded grant project
Other Identifiers
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NIDILRR 90DP0043-03-00
Identifier Type: -
Identifier Source: secondary_id
04-157
Identifier Type: -
Identifier Source: org_study_id
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