Pilot Randomized, Controlled Trial of Testosterone Therapy in Chronic Critically Ill Patients and Its Potential Effects on Weaning From Mechanical Ventilation and Intensive Care Unit-acquired Weakness
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mechanical ventilation dependence
研究概览
简要总结
The researchers intend to investigate possible anabolic effects of bi-weekly exogenous testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control group will receive standard ICU management and will also be followed during ICU stay.
详细描述
For the study chronic critical patients will be included according to criterion of mechanical ventilation by orotracheal tube> 14 consecutive days or mechanical ventilation by tracheostomy> 8 consecutive days and that do not present exclusion criteria.
Patients will be randomized into two follow-up groups: Intervention group with anabolic steroid and control group.
The anabolic steroid intervention group will receive a bi-weekly dose of 200mg intramuscular testosterone cypionate and receive the standard treatment of nutritional therapy and physical therapy. While patients in the control group will receive only the standard treatment of nutrition and physical therapy, without addition of the anabolic drug.
At the beginning of the study and weekly the patients will be evaluated in relation to the muscular profile with diaphragm ultrasound and Medical Research Council (MRC) application. In addition to the collection of serum homograms, leukogram, lipid profile and renal function tests.
Weight and nutritional therapy-related data will be identified in the patient's chart regarding caloric and protein requirement and supply adequacy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals older than 18 years
- •Mechanical ventilation by orotracheal tube for more than 14 consecutive days
- •Mechanical ventilation by tracheostomy for more than 8 consecutive days
排除标准
- •End of life care
- •Known hypersensitivity to formula
- •Venous or arterial thrombosis within last 6 months: ischemic stroke, myocardial infarction, acute peripheral arterial occlusion, acute mesenteric ischemia, deep venous thromboembolism, pulmonary embolism
- •Decompensated congestive heart failure
- •Acute liver failure or acute on chronic liver failure
- •Refractory shock (norepinephrine dose >0.3 mcg/kg/min or equivalent doses of any vasoactive agent)
- •Platelets below <20,000 / mm3 without transfusion plan
- •Personal history of prostate cancer
- •Primary neuromuscular disorders such as myasthenia gravis, Guillain-Barré syndrome, amyotrophic lateral sclerosis, Duchenne Muscular dystrophy
- •Current or prior spinal cord injury
研究组 & 干预措施
Anabolic patients
Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.
干预措施: Testosterone cypionate (Drug)
Anabolic patients
Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.
干预措施: Standard nutrition and physical therapy at ICU (Other)
Control
Standard nutrition and physical therapy at ICU without administration of testosterone cypionate
干预措施: Standard nutrition and physical therapy at ICU (Other)
结局指标
主要结局
Mechanical ventilation dependence
时间窗: 8 weeks
Days of any positive pressure ventilation described in the patient record from the start of the study
次要结局
- Hospital length of stay(9 months)
- ICU length of stay(9 months)
- Ultrasound diaphragm(8 weeks)
- Muscle weakness(8 weeks)