Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 79 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University Hospital, Clermont-Ferrand

Study start

Jun 27, 2019 Actual

Primary completion

Nov 1, 2023 Actual

Study completion

Nov 1, 2023 Actual

First posted

Sep 19, 2018 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.