Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,126
- 试验地点
- 1
- 主要终点
- Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.
研究概览
简要总结
The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various agents are assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.
详细描述
The University of Texas Medical Branch(UTMB) project improves outcomes for severely burned children by instituting and evaluating two modifications to traditional rehabilitation: (1) an intensive rehabilitation program including active resistance exercise; (2) long term administration of anabolic agents.
Effectiveness is assessed by comparison with functional outcomes achieved in traditional outpatient rehabilitation programs. Results indicate improvement in strength, endurance and bone density with these modifications. The project also maintains a longitudinal database that includes measures of cardiopulmonary function, growth and maturation, bone density, range of motion, and psychosocial adjustment.
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 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn 30% Total Body Surface Area (TBSA) or greater
- •Ages 0-80 yrs
- •Negative pregnancy test
- •Informed consent
排除标准
- •Untreated malignancy, known history of AIDS, Aids Related Complex, HIV
- •Recent history of myocardial infarction (6 wks)
- •Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
- •Chronic glucocorticoid or non steroidal anti inflammatory drug therapy
- •Diabetes mellitus prior to burn injury
- •Renal insufficiency (defined by creatinine >3.0 mg/dl)
- •Hepatic disease (bilirubin > 3.0 mg/dl)
研究组 & 干预措施
5
Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
1
Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
1
Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
1
Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
干预措施: Humatrope (Drug)
2
Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
2
Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
2
Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
干预措施: Ketoconazole (Drug)
3
Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
3
Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
3
Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Oxandrolone (Drug)
4
Propranolol PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
7
Placebo PO to be given for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
4
Propranolol PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
4
Propranolol PO given daily throughout hospitalization for up to 2 years post burn
干预措施: Propranolol (Drug)
5
Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
5
Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
干预措施: Oxandrolone and propranolol combined (Drug)
6
Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
干预措施: Stable Isotope Infusion Study (Procedure)
6
Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
6
Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
干预措施: Humatrope and propranolol combined (Drug)
7
Placebo PO to be given for up to 2 years post burn
干预措施: Collection of blood and tissues (Procedure)
7
Placebo PO to be given for up to 2 years post burn
干预措施: Placebo (Drug)
8
Exercise--hospital supervised intensive exercise program
干预措施: Stable Isotope Infusion Study (Procedure)
8
Exercise--hospital supervised intensive exercise program
干预措施: Collection of blood and tissues (Procedure)
8
Exercise--hospital supervised intensive exercise program
干预措施: Exercise--Hospital supervised intensive exercise program (Behavioral)
9
Exercise--home or community based exercise program
干预措施: Stable Isotope Infusion Study (Procedure)
9
Exercise--home or community based exercise program
干预措施: Collection of blood and tissues (Procedure)
9
Exercise--home or community based exercise program
干预措施: Home exercise program (Behavioral)
结局指标
主要结局
Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.
时间窗: Admission to burn unit and up to 2 years post burn and yearly after that
Dual Energy X-Ray Absorptiometry measurements will be utilized to measure muscle wasting
次要结局
未报告次要终点