Patients receiving invasive mechanical ventilation and treatment with a vasoactive drug within 96 hours of ICU admission will be screened.
Conditions
Interventions
Trade Name: Androgel
Product Name: Androgel
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 16.2-
Sponsors
CHU DE CLERMONT-FERRAND
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: • History of prostate cancer • History of breast cancer • PSA = 4 ng/ml • ICU length of stay > 120 h before enrollment • Moribund • Pre-existing illness with a life expectancy of 80 years • Pregnancy • Breast feeding • Patients under legal guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that daily administration of testosterone gel, 101.25 mg in men and 20.25 mg in women, during the acute phase of critical illness, is more effective than placebo in improving physical performance 3 months after ICU admission.;Secondary Objective: To demonstrate that daily administration of testosterone gel 101.25 mg in men and 20.25 in women, during the acute phase of critical illness is more effective than placebo in: •Improving physical performance •Increasing muscle strength •Improving functional status •Improving oxygen muscular consumption •Decreasing hospitalization rate •Decreasing duration of hospital admissions To evaluate the impact of testosterone gel on: •Duration of invasive mechanical ventilation •Ventilator-associated pneumonia rate •Bloodstream infection rate •Length of stay in the ICU •Length of stay in hospital •Mortality rate at 28 days after ICU admission •Mortality rate at 90 days after ICU admission •Hospital mortality rate •ICU mortality rate To assess the safety of testosterone gel in critically ill patients ;Primary end point(s): •Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres.;Timepoint(s) of evaluation of this end point: 3 months after ICU admission | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Physical performance 3, 6 months and 1 year after ICU admission ? 6 MWD at 6 months and 1 year ? 6 MWD in metres at 6 months and 1 year ? Percentage of patients with increase of 30 m between 2 assessments ? Percentage of patients with 6 MWD at 6 months > 60% the distance walked in an age-matched and sex-matched control population (14,78) ? Percentage of patients with 6 MWD at 1 year > 65% the distance walked in an age-matched and sex-matched control population (14,78) ? Percentage of patients with Short Physical Performance Battery < 10 at 3, 6 months and 1 year ? Physical component of SF 36 (Medical Outcomes Study 36 Item Short Form Health Survey) at 3, 6 months and 1 year (appendix 3) • Muscle strength on ICU discharge at 3, 6 months and 1 year after ICU admission ? Handgrip: Kg and percentage of the predicted force ? MRC (appendix 4) • Muscle mass at 3, 6 and 1 year after ICU admission ? MAMC • Functional status at 3, 6 months and 1 year after ICU admission ? Composite score of 11 items of ADL and IADL (appendices 5 and 6) • Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission • Hospitalization rate at 3, 6 months and 1 year after ICU admission • Duration of new hospitalisation at 3, 6 months and 1 year after ICU admission • Ventilation free days at day 28 • Ventilator-associated pneumonia rate • Nosocomial infections rate • Length of stay in the ICU • Length of stay in hospital • Mortality rate at day 28 • Mortality rate at day 90 • ICU mortality rate • Hospital mortality rate • Safety of testosterone gel ? Hypertension ? Cardiovascular ischemic events (Appendix 8) (64) ? Obstructive sleep apnea ? Increase in hemoglobin, hematocrit and red blood cells counts ? Alopecia, urticaria, acne, erythema ? Vertigo, paresthesia ? Depression, anxiety ? Gynaecomastia ? Oedema, weight gain ;Timepoint(s) of evaluation of this end point: 3, 6 months and 1 year after ICU | — |
Countries
France
Contacts
Public ContactDirection de la Recherche Clinique
CHU de Clermont-Ferrand
Outcome results
None listed