BurnsPhase 2/3NCT03038594
Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
A Phase 2/3 study testing Somatropin and 0.09% Saline Solution in people with Burns and Growth Hormone Treatment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Burns, Growth Hormone Treatment
- What is being tested?
- Somatropin and 0.09% Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 30 Nov 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old
- Over 30% total body surface area burn
- Provide consent and comprehend English or Spanish
Who cannot join
- History of AIDS, AIDS-related complex, or HIV
- History of or current hepatitis B or C
- Pregnancy
- History of or Active Malignancy
- Insulin dependent diabetes mellitus type I prior to admission
- Insulin dependent diabetes mellitus type II (up to 12 months prior to admission)
Show all 9Show fewer
- Other hyperglycemic disorders [not including transient post-burn/trauma hyperglycemia]
- Current oral corticosteroid treatment
- Currently participating in another interventional clinical trial at UTMB
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77550-1220
About this study
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.
Read the 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.
- Conditions
- Burns, Growth Hormone Treatment
- Being tested
- Somatropin, 0.09% Saline Solution
- Keywords
- Burns, Growth Hormone, Lean Body Mass, Strength, Exercise Endurance
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Also called Genotropin, Growth Hormone (GH)
0.09% Saline SolutionDrug
Also called Placebo, Control
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone | Experimental | 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. Receives: Drug: Somatropin |
| 0.09% saline solution | Placebo comparator | Daily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn. Receives: Drug: 0.09% Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Measured: At baseline
Lean body mass
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Measured: 6 months post burn-injury
Lean body mass
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Measured: 12 months post burn-injury
Lean body mass
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Measured: 18 months post burn-injury
Lean body mass
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Measured: 24 months post burn-injury
Secondary outcomes (33)
Change in Muscle strength (peak torque)
resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle strength ( total work)
resistance testing muscle strength (Biodex isokinetic dynamometer)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle strength (average power)
resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle grip strength (maximum power)
testing muscle strength (assessed by hand dynamometer)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle endurance (maximum power)
testing muscle endurance (assessed by Bruce treadmill test)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Resting energy expenditure (REE)
Indirect calorimetry
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in resting heart rate
electrocardiogram (EKG) readings
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in liver size
Ultrasound readings
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in cardiac stroke volume
echocardiogram readings
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in cardiac output
Echocardiogram readings
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in respiratory quotient
Indirect calorimetry
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Total body fat
Dual-Energy X-ray Absorptiometry (DEXA)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in percentage of total body fat
Dual-Energy X-ray Absorptiometry (DEXA)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in bone mineral content
Dual-Energy X-ray Absorptiometry (DEXA)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in bone mineral density
Dual-Energy X-ray Absorptiometry (DEXA)
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Maximal oxygen consumption
Six-minute walk test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in respiratory fatigue
Six-minute walk test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in leg fatigue
Six-minute walk test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle protein synthesis rate
Deuterium water
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Hypertrophic scar development
Vancouver Scar Scale
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Forced vital capacity (FVC)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in forced expiratory volume in one second (FEV1)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in forced expiratory flow rate between 27-75% of the FVC (FEF25-75)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in FEV1/FVC ratio expressed as a percentage (FEV1/FVC%)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in vital capacity (VC)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in total lung capacity (TLC)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in residual volume (RV)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in functional residual capacity (FRC)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in lung diffusion capacity (DLCO)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in maximum voluntary ventilation (MVV)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in peak expiratory flow (PEF)
Pulmonary function test
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Molecular biomarkers of oxidative and nitrosative stress (isoprostanes, asymmetric dimethylarginine)
Urine analysis
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Changes in quality of life
Questionnaires
Measured: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Nov 2015
- Primary completion2 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Pfizer
- Responsible party
- Sponsor
- Investigators
- Ludwik K Branski, MD, MMS, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038594
- Sponsor's protocol ID
- 19-0298 / 15-0192
- Other IDs
- W81XWH-15-1-0143
- Status last verified
- Feb 2023
- First submitted
- 11 May 2016
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 8255630
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT03038594
- Acronym / sponsor ID
- 19-0298 / 15-0192
- Conditions
- Burns, Growth Hormone Treatment
- Keywords
- Burns, Growth Hormone, Lean Body Mass, Strength, Exercise Endurance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- United States Department of Defense, Pfizer
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone | Experimental | Drug: SomatropinDaily 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. |
| 0.09% saline solution | Placebo comparator | Drug: 0.09% Saline SolutionDaily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years old
- Over 30% total body surface area burn
- Provide consent and comprehend English or Spanish
Key exclusion criteria (9 listed)
- History of AIDS, AIDS-related complex, or HIV
- History of or current hepatitis B or C
- Pregnancy
- History of or Active Malignancy
- Insulin dependent diabetes mellitus type I prior to admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatropinAlso: Genotropin, Growth Hormone (GH) | Drug | Growth Hormone |
| 0.09% Saline SolutionAlso: Placebo, Control | Drug | 0.09% saline solution |
Primary outcome
Lean body mass
Time frame: At baseline
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Lean body mass
Time frame: 6 months post burn-injury
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Lean body mass
Time frame: 12 months post burn-injury
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Lean body mass
Time frame: 18 months post burn-injury
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
Lean body mass
Time frame: 24 months post burn-injury
Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
33 secondary outcomes
Change in Muscle strength (peak torque)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle strength ( total work)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle strength (average power)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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
Change in Muscle endurance (maximum power)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Resting energy expenditure (REE)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in resting heart rate
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in liver size
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in cardiac stroke volume
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in cardiac output
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in respiratory quotient
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Total body fat
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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
Change in bone mineral content
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in bone mineral density
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Maximal oxygen consumption
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in respiratory fatigue
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in leg fatigue
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Muscle protein synthesis rate
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Hypertrophic scar development
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in Forced vital capacity (FVC)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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
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
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
Change in vital capacity (VC)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in total lung capacity (TLC)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in residual volume (RV)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in functional residual capacity (FRC)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in lung diffusion capacity (DLCO)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in maximum voluntary ventilation (MVV)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Change in peak expiratory flow (PEF)
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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
Changes in quality of life
Time frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 8255630Stylianos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludwik K Branski, MD, MMS principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Somatropin and 0.09% Saline Solution in people with Burns and Growth Hormone Treatment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.