Informations générales (source: ClinicalTrials.gov)
Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients (TestICUs)
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
juin 2019
juin 2025
05 juillet 2025
Critically ill patients experience major insults that lead to increased protein
catabolism. Hypermetabolism occurs early and rapidly during the first week of critical
illness to provide amino acids for the production of energy via gluconeogenesis, and also
for the synthesis of acute phase proteins and repair of tissue damage. During acute
phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid
release. Under stress conditions, protein synthesis cannot match the increased rate of
muscle proteolysis because of a state of anabolism resistance, which limits uptake of
amino acids into muscles. Hypermetabolism results in a significant loss of lean body mass
with an impact on weaning from the ventilator and muscle recovery. Functional disability
may be long term sometimes with no full return to normal.
In critically ill patients, severe and persistent testosterone deficiency is very common
and is observed early after ICU admission. This acquired hypogonadism promotes the
persistent loss of skeletal muscle protein and is related to poor outcome.
Administration of testosterone induces skeletal muscle fiber hypertrophy, decreases
protein breakdown in healthy young men and burned patients. It has been repeatedly shown
that testosterone treatment enhances muscle mass and strength in young and older
hypogonadal men and women and can improve physical performance.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chu Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Tous
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
-
- 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
-
- 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