Effects of early testosterone gel administration on physical performance in the critically ill
- Conditions
- Patients receiving invasive mechanical ventilation and treatment with a vasoactive drug within 96 hours of ICU admission will be screened.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2019-004599-20-FR
- Lead Sponsor
- CHU DE CLERMONT-FERRAND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
•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
•History of prostate cancer
•History of breast cancer
•PSA = 4 ng/ml
•ICU length of stay > 120 h before enrollment
•Moribund
•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
•Pregnancy
•Breast feeding
•Patients under legal guardianship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method