Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients
- Conditions
- - Hypermetabolism in ICU, loss of muscle mass and functional disability after ICU - ICU acquired hypogonadism - Treatment with testosterone gel in ICUTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2017-004978-34-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
- Not specified
- Target Recruitment
- 30
-Males and females aged over 18 years receiving invasive mechanical ventilation
-Invasive mechanical ventilation expected to be required for more than 48 hours
-Treatment with vasoactive drugs
-Written informed consent obtained from the legal representative
-Social security cover
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
•History of prostate or breast cancer, prostatic specific antigen (PSA) = 4 ng/ml
•ICU length of stay > 72 h before enrollment
•Moribund defined as having a score SAPS II > 75 12 hours after admission
•Pre-existing illness with a life expectancy of <6 months
•Cardiac arrest
•Preexistent cognitive impairment or language barrier
•Acute intracranial or spinal cord injury
•Acute hemorrhagic or ischemic stroke
•Neuromuscular disease (Guillain-Barré, myasthenia)
•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 or breast feeding
•Patient 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
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