Using testosterone gel to treat low testosterone in critically ill ICU patients
Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients
PHASE2 · University Hospital, Clermont-Ferrand · NCT03678233
This study tests if using testosterone gel can help critically ill patients in the ICU regain muscle mass and recover better while they are on a ventilator.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT03678233 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of testosterone gel in restoring normal testosterone levels in critically ill patients who are mechanically ventilated and experiencing ICU acquired hypogonadism. The study is a phase II, single-center, open-label, parallel randomized controlled trial conducted at the university hospital of Clermont-Ferrand. Participants will receive Androgel® to assess its impact on muscle mass and recovery during their ICU stay. The trial aims to address the significant loss of lean body mass and functional disability associated with critical illness.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are receiving invasive mechanical ventilation for more than 48 hours and are undergoing treatment with vasoactive drugs.
Not a fit: Patients with a history of prostate or breast cancer, severe pre-existing conditions, or those who are moribund may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes and quality of life for critically ill patients by restoring testosterone levels.
How similar studies have performed: While similar studies have explored testosterone treatment in various populations, this specific approach in critically ill ICU patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * - 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 Exclusion Criteria: * - 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 on judicial protection
Where this trial is running
Clermont-Ferrand
- Chu Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
Study contacts
- Principal investigator: Konstantinos BACHOUMAS — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: drci@chu-clermontferrand.fr
- Phone: 04 73 75 49 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypermetabolism in ICU, Loss of Muscle Mass, Functional Disability After ICU, ICU Acquired Hypogonadism, Treatment With Testosterone Gel in ICU, hypermetabolism, hypogonadism, testosterone