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

This study is currently recruiting participants.
Verified May 2017 by The University of Texas Medical Branch, Galveston
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675714
First Posted: May 12, 2008
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
U.S. Department of Education
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  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
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

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, 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 ]

Estimated Enrollment: 1100
Study Start Date: January 2004
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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 Medical Branch, Galveston
U.S. Department of Education
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
Study Director: David N Herndon, MD University of Texas
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Diaz EC, Herndon DN, Lee J, Porter C, Cotter M, Suman OE, Sidossis LS, Børsheim 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, Børsheim 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, Børsheim 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. Review.
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.
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. α-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.

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 Submitted: December 26, 2007
First Posted: May 12, 2008
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
Anabolic Agents
Propranolol
Metoprolol
Ketoconazole
Itraconazole
Hydroxyitraconazole
Fluconazole
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


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