Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/20/2019 |
| Start Date: | November 2015 |
| End Date: | October 2020 |
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.
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.
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.
INCLUSION CRITERIA
- 18-85 years old
- Over 30% total body surface area burn
EXCLUSION CRITERIA
- History of AIDS, AIDS-related complex, or HIV
- History of hepatitis
- Pregnancy
- History of or Active Malignancy
- History of Insulin Dependent Diabetes Mellitus Type I or II
- Other hyperglycemic disorders [not including transient post-burn/trauma hyperglycemia]
We found this trial at
2
sites
815 Market Street
Galveston, Texas 77555
Galveston, Texas 77555
Phone: 409-770-6589
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Ludwik K Branski, MD, MMS
Phone: 409-770-6589
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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