2024-519156-93-00招募中2 期
TestICUs : Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial.
University Hospital Of Clermont-Ferrand11 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年12月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 11
- 主要终点
- • Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters
研究概览
简要总结
To demonstrate that daily administration of testosterone gel, 101.25 mg in men and 20.25 mg in women, during the acute phase of critical illness, is more effective than placebo in improving physical performance 3 months after ICU admission.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females aged over 18 years
- •Negative pregnancy test (b-HCG) in female patient of childbearing potential
- •COVID-19 or not
- •Patient on invasive mechanical ventilation for an expected total duration of at least 48 hours and still on invasive mechanical ventilation at the time of inclusion.
- •Written informed consent obtained from the patient or the legal representative
- •Social security cover
- •Contraception : Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 7 months after the last treatment intake Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 4 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 4 months after the last treatment intake
排除标准
- •History of prostate cancer
- •Breast feeding
- •Patients under legal guardianship
- •History of breast cancer
- •Prostate cancer suspected or confirmed
- •Breast cancer suspected or confirmed
- •PSA ≥ 4 ng/ml
- •ICU length of stay > 120 h before enrollment
- •Pre-existing illness with a life expectancy of <6 months not connected to the acute pathology justifying ICU admission
- •Recent intracranial or spinal cord injury (< 1 month)
- •Recent hemorrhagic or ischemic stroke (< 1 month)
- •Language barrier
- •Patient deprived of liberty
- •Neuromuscular disease
- •Cardiac arrest in non-shockable rhythm
- •Pre-existing cognitive impairment with an MMS score < 20
- •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
结局指标
主要结局
• Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters
• Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters
次要结局
- Physical performance 3, 6 months and 1 year after ICU admission : 6 MWD at 6 months and 1 year, Percentage of patients with Short Physical Performance Battery < 10 at 3, 6 months and 1 year, Physical component of SF 36 (Medical Outcomes Study 36 Item Short Form Health Survey) at 3, 6 months and 1 year
- Muscle strength on ICU discharge at 3, 6 months and 1 year after ICU admission: - Handgrip: Kg and percentage of the predicted force, - MRC
- Muscle mass at 3, 6 and 1 year after ICU admission : MAMC
- Length of stay in hospital
- Functional status at 3, 6 months and 1 year after ICU admission : - Composite score of 11 items of ADL and IADL
- Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission
- Ventilation free days at day 28
- Length of stay in the ICU
- Mortality rate at day 28
- Mortality rate at day 90
- ICU mortality rate
- Hospital mortality rate
- Safety of testosterone gel : - Hypertension, - Cardiovascular events, - Obstructive sleep apnea, - Increase in hemoglobin, hematocrit and red blood cells counts, - Alopecia, urticaria, acne, erythema, - Vertigo, paresthesia, - Depression, anxiety, - Gynaecomastia, - Oedema, weight gain, - insulin requirements, - Fractures
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (11)
Loading locations...
相似试验
招募中
3 期
TRAP study: Testosterone for Androgen Receptor Polymorphism.2024-510596-37-01Instituto Bernabeu S.L.100
进行中（未招募）
1 期
TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney TransplantationNCT07287800University of California, Los Angeles50
招募中
1 期
Effects of early testosterone gel administration on physical performance in the critically illEUCTR2019-004599-20-FRCHU DE CLERMONT-FERRAND600
尚未招募
2 期
Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled TrialDyspareuniaNCT07260825TriHealth Inc.44
招募中
4 期
Bioequivalence of Testosterone Transdermal Gel in Healthy Female Participants.2025-523300-77-00Laboratorios Leon Farma S.A.48