Burns
Conditions
Keywords
burns
Brief summary
The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
Detailed description
This study involves research and the investigators hope to learn the following: how or what effect one or more anabolic (tissue building) agents have on muscle metabolism, wound healing, and immune function after severe burn. The agents include the following: growth hormone, insulin-like growth factor-1 in combination with its binding proteins, insulin, Beta-adrenergic blockers, Alpha Adrenergic Agonist, anabolic steroids such as testosterone, Oxandrolone and nandrolone, ketoconazole and its derivatives, dehydroepiandrosterone, fenofibrate, diet or the application of skin substitute.
Interventions
PROCEDUREStable 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)
DRUGInsulin High Dose
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
DRUGoxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
DRUGPropranolol
Propranolol to be given daily throughout hospitalization until 95% wound healing.
DRUGGrowth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
DRUGInsulin Low Dose
Insulin administered IV until 95% wound healing
DRUGIGF-1/IGFBP-3
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
DRUGItraconazole
Itraconazole administered until 95% wound healing
DRUGGrowth Hormone and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
DRUGOxandrolone and Propranolol
Oxandrolone and Propranolol
Administration of Placebo or Control until 95% wound healing
Sponsors
National Institute of General Medical Sciences (NIGMS)
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient is between 0 and 90 years of age * 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
* Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study | Admission to burn unit to 95% wound healing | At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Rate of Wound Healing | Admission to burn unit to 95% wound healing | At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are. |
| Incidence of Morbidity and Mortality | Admission to burn unit to discharge | At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are. |
| Incidence of Sepsis | Admission to burn unit to 95% wound healing | At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are. |
Countries
United States
Participant flow
Recruitment details
Patients admitted to burn unit with \>40% burn or greater
Pre-assignment details
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Participants by arm
| Arm | Count |
|---|---|
| Growth Hormone Administration 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. | 0 |
| Insulin High Dose Administration 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: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed. | 0 |
| Oxandrolone Administration 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. | 0 |
| Propranolol Administration 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. | 0 |
| Itraconazole Administration Itraconazole administered throughout hospitalization 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)
Itraconazole administered throughout hospitalization until 95% wound healing. | 0 |
| IGF-1/IGFBP-3 Comparator IGF-1/IGFBP-3 administered daily to 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)
IGF-1/IGFBP-3 administered until 95% wound healing | 0 |
| Insulin Low Dose Administration Insulin IV administered continuously through hospitalization to 95% wound healing. | 0 |
| Growth Hormone and Propranolol Administration Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing.
Includes stable isotope infusion studies. | 0 |
| Oxandrolone and Propranolol Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing.
Includes stable isotope infusion studies | 0 |
| Control or Placebo Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Time frame: Admission to burn unit to 95% wound healing
Population: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Secondary
Improved Rate of Wound Healing
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Time frame: Admission to burn unit to 95% wound healing
Population: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Secondary
Incidence of Morbidity and Mortality
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Time frame: Admission to burn unit to discharge
Population: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Secondary
Incidence of Sepsis
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Time frame: Admission to burn unit to 95% wound healing
Population: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.