EUCTR2019-004599-20-FR招募中1 期
Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial - TestICUs
CHU DE CLERMONT-FERRAND0 个研究点目标入组 600 人开始时间: 2021年5月25日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Males and females aged over 18 years
- •COVID-19 or not
- •Invasive mechanical ventilation expected to be required for more than 48 hours
- •Written informed consent obtained from the patient or the legal representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •History of prostate cancer
- •History of breast cancer
- •PSA = 4 ng/ml
- •ICU length of stay > 120 h before enrollment
- •Pre-existing illness with a life expectancy of <6 months
- •Recent intracranial or spinal cord injury (< 1 month)
- •Recent hemorrhagic or ischemic stroke( < 1 month)
- •Neuromuscular disease
- •Cardiac arrest in non-shockable rhythm
- •Pre-existing cognitive impairment or language barrier
- •Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not excluded)
- •Documented allergy to testosterone
- •Age > 80 years
- •Breast feeding
- •Patients under legal guardianship
研究者
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