Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 644
- 试验地点
- 1
- 主要终点
- Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
研究概览
简要总结
The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Propranolol
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Stable Isotope Infusion study (Procedure)
Growth Hormone and Propranolol
Growth Hormone and Propranolol will be administered until 95% wound healing.
干预措施: Stable Isotope Infusion study (Procedure)
Growth Hormone
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Stable Isotope Infusion study (Procedure)
Growth Hormone
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Growth Hormone (Drug)
Insulin High Dose
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Stable Isotope Infusion study (Procedure)
Insulin High Dose
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Insulin High Dose (Drug)
Oxandrolone
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Stable Isotope Infusion study (Procedure)
Oxandrolone
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
干预措施: oxandrolone (Drug)
Propranolol
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
干预措施: Propranolol (Drug)
IGF-1/IGFBP-3
IGF-1/IGFBP-3 will be administered until 95% wound healing
干预措施: Stable Isotope Infusion study (Procedure)
IGF-1/IGFBP-3
IGF-1/IGFBP-3 will be administered until 95% wound healing
干预措施: IGF-1/IGFBP-3 (Drug)
Insulin Low Dose
Insulin Low Dose will be administered until 95% wound healing.
干预措施: Stable Isotope Infusion study (Procedure)
Insulin Low Dose
Insulin Low Dose will be administered until 95% wound healing.
干预措施: Insulin Low Dose (Drug)
Itraconazole
Itraconazole will be administered until 95% wound healing.
干预措施: Stable Isotope Infusion study (Procedure)
Itraconazole
Itraconazole will be administered until 95% wound healing.
干预措施: Itraconazole (Drug)
Growth Hormone and Propranolol
Growth Hormone and Propranolol will be administered until 95% wound healing.
干预措施: Growth Hormone and Propranolol (Drug)
Oxandrolone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
干预措施: Stable Isotope Infusion study (Procedure)
Oxandrolone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
干预措施: Oxandrolone and Propranolol (Drug)
Control/Placebo
Placebo or Control will be administered until 95% wound healing
干预措施: Stable Isotope Infusion study (Procedure)
Control/Placebo
Placebo or Control will be administered until 95% wound healing
干预措施: Placebo or Control (Drug)
结局指标
主要结局
Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
时间窗: 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.
次要结局
- Incidence of Sepsis(Admission to burn unit to 95% wound healing)
- Improved Rate of Wound Healing(Admission to burn unit to 95% wound healing)
- Incidence of Morbidity and Mortality(Admission to burn unit to discharge)