<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03038594</url>
  </required_header>
  <id_info>
    <org_study_id>19-0298 / 15-0192</org_study_id>
    <secondary_id>W81XWH-15-1-0143</secondary_id>
    <nct_id>NCT03038594</nct_id>
  </id_info>
  <brief_title>Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients</brief_title>
  <official_title>Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have previously demonstrated that burn injury causes severe muscle wasting,&#xD;
      weight and height retardation, and systemic protein catabolism in pediatric and adult burned&#xD;
      patients. The persistent loss of muscle impairs the quality of life of the burned patients,&#xD;
      and it also delays autonomy and reintegration into the community. In 2009, the investigators&#xD;
      showed that the daily injection of recombinant human growth hormone (GH) for nine months post&#xD;
      discharge significantly increased height and weight, as well as lean body mass, in pediatric&#xD;
      burned subjects. Our long-term goal is to improve the quality of life of burn patients by&#xD;
      preventing height, weight, and muscle loss that may occur from severe protein catabolism. The&#xD;
      objectives of this application are to a) attenuate height and weight in burned patients with&#xD;
      the administration of GH, b) prevent or reverse loss of muscle and strength in these&#xD;
      patients, and c) collect pilot data about cardiopulmonary parameters, scar assessments, and&#xD;
      muscle metabolism. Our central hypothesis is that the administration of GH will restore&#xD;
      depleted levels of growth hormone and will lead to prevention of lean body mass loss and bone&#xD;
      mineral content, improve rehabilitation, and accelerate reintegration of severely burned&#xD;
      patients. The investigators will administer either placebo or GH (daily subcutaneous&#xD;
      injections of 0.05 mg/kg/day of GH [somatropin, Genotropin, Pfizer, New York, NY] to adult&#xD;
      burn subjects (n=31 per group, 18-85 years, &gt;30% total body surface burns) for nine months&#xD;
      beginning one week prior to discharge. Both groups will be studied for a total of two years.&#xD;
      The following aims will be tested: 1) determine the effects of GH supplementation on body&#xD;
      composition, such as lean body mass loss, muscle strength, and exercise endurance; and 2)&#xD;
      assess whether rehabilitation and subsequent reintegration of severely burned patients into&#xD;
      society can be accelerated. Investigators will measure changes in lean body mass, muscle&#xD;
      strength and exercise endurance during the acute hospital stay, discharge, and long-term&#xD;
      follow-up visits (6, 12, 18, and 24 months after burn), as well as secondary endpoints such&#xD;
      as cardiopulmonary variables, hypertrophic scar development, quality of life questionnaires,&#xD;
      and concentrations of relevant hormones, cytokines, and oxidative stress markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Either recombinant human growth hormone (daily subcutaneous injections of 0.05 mg/kg/day of&#xD;
      GH at discharge [somatropin, Genotropin, Pfizer, New York, NY]; 0.025 mg/kg/day of GH&#xD;
      titrated the week before discharge) or placebo (n=31) will be administered to adult burned&#xD;
      subjects (n= 31, 18-85 years) after screening and voluntary consent who have ≥30% TBSA&#xD;
      assessed by either the Lund and Browder chart or the 'rule of nines' method during excisional&#xD;
      surgery. It will be administered daily for 9 months beginning the week before discharge, and&#xD;
      the primary and secondary endpoints will be collected during the acute hospital stay,&#xD;
      discharge, and long-term follow-up visits (6, 12, 18, and 24 months after burn injury).&#xD;
      Additionally, subjects will be contacted frequently [most likely 1 week, 1 month, and 2&#xD;
      months post discharge by telephone] to ensure that there are no adverse events or concerns&#xD;
      with their study drug, as well as visit with them during their clinical visits that address&#xD;
      their post-burn needs. All subjects will receive similar standard medical care and treatment&#xD;
      from the time of emergency admission until their discharge.&#xD;
&#xD;
      Growth hormone will be used to potentially attenuate losses in height, weight, muscle and&#xD;
      bone, reverse the oxidative stress of burn injury and, in the process, decrease the secondary&#xD;
      consequences of burn injury, including organ dysfunction. This may improve the quality of&#xD;
      life of the burn patient by preventing pathophysiology that may result from muscle and bone&#xD;
      loss and may reduce hospital stay. Our research will lay the foundation for the future&#xD;
      development of effective, safe, and economic therapeutic interventions to treat burn&#xD;
      injury-associated metabolic abnormalities. Also, it will provide the basis for the&#xD;
      development of supplemental regulations and pharmacotherapy to treat burn patients with GH.&#xD;
      The risks are very reasonable in relation to the anticipated benefits to our subjects because&#xD;
      a) GH at a higher dose has been tested in pediatric burned subjects with minor adverse&#xD;
      events, and b) the subjects will be monitored consistently.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 2, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>At baseline</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA) measured in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>6 months post burn-injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA) measured in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>12 months post burn-injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA) measured in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>18 months post burn-injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA) measured in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>24 months post burn-injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA) measured in grams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle strength (peak torque)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle strength ( total work)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>resistance testing muscle strength (Biodex isokinetic dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle strength (average power)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle grip strength (maximum power)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>testing muscle strength (assessed by hand dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle endurance (maximum power)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>testing muscle endurance (assessed by Bruce treadmill test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting energy expenditure (REE)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>electrocardiogram (EKG) readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in liver size</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Ultrasound readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac stroke volume</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>echocardiogram readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Echocardiogram readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory quotient</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total body fat</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of total body fat</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone mineral content</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone mineral density</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Dual-Energy X-ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maximal oxygen consumption</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory fatigue</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in leg fatigue</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle protein synthesis rate</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Deuterium water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertrophic scar development</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Vancouver Scar Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Forced vital capacity (FVC)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expiratory flow rate between 27-75% of the FVC (FEF25-75)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1/FVC ratio expressed as a percentage (FEV1/FVC%)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vital capacity (VC)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total lung capacity (TLC)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in residual volume (RV)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional residual capacity (FRC)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung diffusion capacity (DLCO)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximum voluntary ventilation (MVV)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak expiratory flow (PEF)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Pulmonary function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Molecular biomarkers of oxidative and nitrosative stress (isoprostanes, asymmetric dimethylarginine)</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Urine analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury</time_frame>
    <description>Questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Burns</condition>
  <condition>Growth Hormone Treatment</condition>
  <arm_group>
    <arm_group_label>Growth Hormone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily subcutaneous injections of 0.05 mg/kg/day of Growth Hormone [somatropin, Genotropin, Pfizer, New York, NY] will be administered, from one week prior to discharge until 9 months post-burn.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.09% saline solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatropin</intervention_name>
    <arm_group_label>Growth Hormone</arm_group_label>
    <other_name>Genotropin, Growth Hormone (GH)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.09% Saline Solution</intervention_name>
    <arm_group_label>0.09% saline solution</arm_group_label>
    <other_name>Placebo, Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  18-85 years old&#xD;
&#xD;
          -  Over 30% total body surface area burn&#xD;
&#xD;
          -  Provide consent and comprehend English or Spanish&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  History of AIDS, AIDS-related complex, or HIV&#xD;
&#xD;
          -  History of or current hepatitis B or C&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of or Active Malignancy&#xD;
&#xD;
          -  Insulin dependent diabetes mellitus type I prior to admission&#xD;
&#xD;
          -  Insulin dependent diabetes mellitus type II (up to 12 months prior to admission)&#xD;
&#xD;
          -  Other hyperglycemic disorders [not including transient post-burn/trauma hyperglycemia]&#xD;
&#xD;
          -  Current oral corticosteroid treatment&#xD;
&#xD;
          -  Currently participating in another interventional clinical trial at UTMB&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ludwik K Branski, MD, MMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77550-1220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stylianos S, Eichelberger MR. Pediatric trauma. Prevention strategies. Pediatr Clin North Am. 1993 Dec;40(6):1359-68. doi: 10.1016/s0031-3955(16)38666-7.</citation>
    <PMID>8255630</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burns</keyword>
  <keyword>Growth Hormone</keyword>
  <keyword>Lean Body Mass</keyword>
  <keyword>Strength</keyword>
  <keyword>Exercise Endurance</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03038594/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03038594
org study id: 19-0298 / 15-0192
secondary id: W81XWH-15-1-0143
nct id: NCT03038594
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators have previously demonstrated that burn injury causes severe muscle wasting,
      weight and height retardation, and systemic protein catabolism in pediatric and adult burned
      patients. The persistent loss of muscle impairs the quality of life of the burned patients,
      and it also delays autonomy and reintegration into the community. In 2009, the investigators
      showed that the daily injection of recombinant human growth hormone (GH) for nine months post
      discharge significantly increased height and weight, as well as lean body mass, in pediatric
      burned subjects. Our long-term goal is to improve the quality of life of burn patients by
      preventing height, weight, and muscle loss that may occur from severe protein catabolism. The
      objectives of this application are to a) attenuate height and weight in burned patients with
      the administration of GH, b) prevent or reverse loss of muscle and strength in these
      patients, and c) collect pilot data about cardiopulmonary parameters, scar assessments, and
      muscle metabolism. Our central hypothesis is that the administration of GH will restore
      depleted levels of growth hormone and will lead to prevention of lean body mass loss and bone
      mineral content, improve rehabilitation, and accelerate reintegration of severely burned
      patients. The investigators will administer either placebo or GH (daily subcutaneous
      injections of 0.05 mg/kg/day of GH [somatropin, Genotropin, Pfizer, New York, NY] to adult
      burn subjects (n=31 per group, 18-85 years, >30% total body surface burns) for nine months
      beginning one week prior to discharge. Both groups will be studied for a total of two years.
      The following aims will be tested: 1) determine the effects of GH supplementation on body
      composition, such as lean body mass loss, muscle strength, and exercise endurance; and 2)
      assess whether rehabilitation and subsequent reintegration of severely burned patients into
      society can be accelerated. Investigators will measure changes in lean body mass, muscle
      strength and exercise endurance during the acute hospital stay, discharge, and long-term
      follow-up visits (6, 12, 18, and 24 months after burn), as well as secondary endpoints such
      as cardiopulmonary variables, hypertrophic scar development, quality of life questionnaires,
      and concentrations of relevant hormones, cytokines, and oxidative stress markers.
Either recombinant human growth hormone (daily subcutaneous injections of 0.05 mg/kg/day of
      GH at discharge [somatropin, Genotropin, Pfizer, New York, NY]; 0.025 mg/kg/day of GH
      titrated the week before discharge) or placebo (n=31) will be administered to adult burned
      subjects (n= 31, 18-85 years) after screening and voluntary consent who have ≥30% TBSA
      assessed by either the Lund and Browder chart or the 'rule of nines' method during excisional
      surgery. It will be administered daily for 9 months beginning the week before discharge, and
      the primary and secondary endpoints will be collected during the acute hospital stay,
      discharge, and long-term follow-up visits (6, 12, 18, and 24 months after burn injury).
      Additionally, subjects will be contacted frequently [most likely 1 week, 1 month, and 2
      months post discharge by telephone] to ensure that there are no adverse events or concerns
      with their study drug, as well as visit with them during their clinical visits that address
      their post-burn needs. All subjects will receive similar standard medical care and treatment
      from the time of emergency admission until their discharge.

      Growth hormone will be used to potentially attenuate losses in height, weight, muscle and
      bone, reverse the oxidative stress of burn injury and, in the process, decrease the secondary
      consequences of burn injury, including organ dysfunction. This may improve the quality of
      life of the burn patient by preventing pathophysiology that may result from muscle and bone
      loss and may reduce hospital stay. Our research will lay the foundation for the future
      development of effective, safe, and economic therapeutic interventions to treat burn
      injury-associated metabolic abnormalities. Also, it will provide the basis for the
      development of supplemental regulations and pharmacotherapy to treat burn patients with GH.
      The risks are very reasonable in relation to the anticipated benefits to our subjects because
      a) GH at a higher dose has been tested in pediatric burned subjects with minor adverse
      events, and b) the subjects will be monitored consistently.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Lean body mass
time frame: At baseline
description: Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
measure: Lean body mass
time frame: 6 months post burn-injury
description: Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
measure: Lean body mass
time frame: 12 months post burn-injury
description: Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
measure: Lean body mass
time frame: 18 months post burn-injury
description: Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
measure: Lean body mass
time frame: 24 months post burn-injury
description: Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
measure: Change in Muscle strength (peak torque)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
measure: Change in Muscle strength ( total work)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: resistance testing muscle strength (Biodex isokinetic dynamometer)
measure: Change in Muscle strength (average power)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
measure: Change in Muscle grip strength (maximum power)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: testing muscle strength (assessed by hand dynamometer)
measure: Change in Muscle endurance (maximum power)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: testing muscle endurance (assessed by Bruce treadmill test)
measure: Change in Resting energy expenditure (REE)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Indirect calorimetry
measure: Change in resting heart rate
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: electrocardiogram (EKG) readings
measure: Change in liver size
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Ultrasound readings
measure: Change in cardiac stroke volume
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: echocardiogram readings
measure: Change in cardiac output
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Echocardiogram readings
measure: Change in respiratory quotient
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Indirect calorimetry
measure: Change in Total body fat
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Dual-Energy X-ray Absorptiometry (DEXA)
measure: Change in percentage of total body fat
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Dual-Energy X-ray Absorptiometry (DEXA)
measure: Change in bone mineral content
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Dual-Energy X-ray Absorptiometry (DEXA)
measure: Change in bone mineral density
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Dual-Energy X-ray Absorptiometry (DEXA)
measure: Change in Maximal oxygen consumption
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Six-minute walk test
measure: Change in respiratory fatigue
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Six-minute walk test
measure: Change in leg fatigue
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Six-minute walk test
measure: Change in Muscle protein synthesis rate
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Deuterium water
measure: Hypertrophic scar development
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Vancouver Scar Scale
measure: Change in Forced vital capacity (FVC)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in forced expiratory volume in one second (FEV1)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in forced expiratory flow rate between 27-75% of the FVC (FEF25-75)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in FEV1/FVC ratio expressed as a percentage (FEV1/FVC%)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in vital capacity (VC)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in total lung capacity (TLC)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in residual volume (RV)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in functional residual capacity (FRC)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in lung diffusion capacity (DLCO)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in maximum voluntary ventilation (MVV)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in peak expiratory flow (PEF)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Pulmonary function test
measure: Change in Molecular biomarkers of oxidative and nitrosative stress (isoprostanes, asymmetric dimethylarginine)
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Urine analysis
measure: Changes in quality of life
time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
description: Questionnaires
arm group label: Growth Hormone
arm group type: Experimental
description: Daily subcutaneous injections of 0.05 mg/kg/day of Growth Hormone [somatropin, Genotropin, Pfizer, New York, NY] will be administered, from one week prior to discharge until 9 months post-burn.
arm group label: 0.09% saline solution
arm group type: Placebo Comparator
description: Daily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn.
intervention type: Drug
intervention name: Somatropin
arm group label: Growth Hormone
other name: Genotropin, Growth Hormone (GH)
intervention type: Drug
intervention name: 0.09% Saline Solution
arm group label: 0.09% saline solution
other name: Placebo, Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ludwik K Branski, MD, MMS
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
citation: Stylianos S, Eichelberger MR. Pediatric trauma. Prevention strategies. Pediatr Clin North Am. 1993 Dec;40(6):1359-68. doi: 10.1016/s0031-3955(16)38666-7.
PMID: 8255630
responsible party type: Sponsor
mesh term: Hormones
sharing ipd: No
provided document: 