EUCTR2019-004599-20-FR
Active, not recruiting
Phase 1
Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial - TestICUs
CHU DE CLERMONT-FERRAND0 sites600 target enrollmentMay 25, 2021
DrugsAndrogel
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU DE CLERMONT-FERRAND
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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