Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
Condition: Burns; Growth Hormone Treatment
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Somatropin; 0.09% Saline Solution
Intervention type(s): Drug; Drug
Other intervention name(s): Genotropin, Growth Hormone (GH); Placebo, Control
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burns; Growth Hormone; Lean Body Mass; Strength; Exercise Endurance