Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
644 participants
INTERVENTIONAL
2000-07-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control/Placebo
Placebo or Control will be administered until 95% wound healing
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Placebo or Control
Administration of Placebo or Control until 95% wound healing
Growth Hormone
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Insulin High Dose
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Insulin High Dose
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
Oxandrolone
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Propranolol
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Propranolol
Propranolol to be given daily throughout hospitalization until 95% wound healing.
IGF-1/IGFBP-3
IGF-1/IGFBP-3 will be administered until 95% wound healing
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
IGF-1/IGFBP-3
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
Insulin Low Dose
Insulin Low Dose will be administered until 95% wound healing.
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Insulin Low Dose
Insulin administered IV until 95% wound healing
Itraconazole
Itraconazole will be administered until 95% wound healing.
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Itraconazole
Itraconazole administered until 95% wound healing
Growth Hormone and Propranolol
Growth Hormone and Propranolol will be administered until 95% wound healing.
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Growth Hormone and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
Oxandrolone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Oxandrolone and Propranolol
Oxandrolone and Propranolol
Interventions
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Stable Isotope Infusion study
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Insulin High Dose
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Propranolol
Propranolol to be given daily throughout hospitalization until 95% wound healing.
Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Insulin Low Dose
Insulin administered IV until 95% wound healing
IGF-1/IGFBP-3
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
Itraconazole
Itraconazole administered until 95% wound healing
Growth Hormone and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
Oxandrolone and Propranolol
Oxandrolone and Propranolol
Placebo or Control
Administration of Placebo or Control until 95% wound healing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient 18 years and older consents to participate in study protocol. If patient is not able to consent, consent will be obtained from closest family member or legal guardian. Parental permission will be obtained for patients less than 18 years of age. Assent will be obtained from children 7-17 years of age if child is physically/mentally able to do so.
* greater than 30% TBSA burn requiring at least 1 operation with donor sites for skin grafting
Exclusion Criteria
* History of cancer within 5 years
* Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
* Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy
90 Years
ALL
No
Sponsors
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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: PRINCIPAL_INVESTIGATOR
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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Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available.
Kraft R, Herndon DN, Finnerty CC, Shahrokhi S, Jeschke MG. Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome. Ann Surg. 2014 Feb;259(2):381-7. doi: 10.1097/SLA.0b013e31828c4d04.
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.
Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.
Jeschke MG, Kraft R, Emdad F, Kulp GA, Williams FN, Herndon DN. Glucose control in severely thermally injured pediatric patients: what glucose range should be the target? Ann Surg. 2010 Sep;252(3):521-7; discussion 527-8. doi: 10.1097/SLA.0b013e3181f2774c.
Mecott GA, Herndon DN, Kulp GA, Brooks NC, Al-Mousawi AM, Kraft R, Rivero HG, Williams FN, Branski LK, Jeschke MG. The use of exenatide in severely burned pediatric patients. Crit Care. 2010;14(4):R153. doi: 10.1186/cc9222. Epub 2010 Aug 11.
Jeschke MG, Kulp GA, Kraft R, Finnerty CC, Mlcak R, Lee JO, Herndon DN. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial. Am J Respir Crit Care Med. 2010 Aug 1;182(3):351-9. doi: 10.1164/rccm.201002-0190OC. Epub 2010 Apr 15.
Gauglitz GG, Herndon DN, Kulp GA, Meyer WJ 3rd, Jeschke MG. Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn. J Clin Endocrinol Metab. 2009 May;94(5):1656-64. doi: 10.1210/jc.2008-1947. Epub 2009 Feb 24.
Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.
Other Identifiers
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