600
Participants
Start Date
July 21, 2023
Primary Completion Date
September 1, 2025
Study Completion Date
April 1, 2027
Androgel Topical Product
AndroGel® will be applied daily to the upper arms/shoulders at 9:00 am. The daily dose will be 101.25 mg in men and 20.25 mg in women. AndroGel® will be administered within 24 hours after inclusion for a period of 28 days or until hospital discharge. For patients discharged from ICU before day 28, AndroGel® will be administered in hospital wards to complete the 28 days of treatment or until hospital discharge
Placebo
Placebo gel will be applied daily to the upper arms/shoulders at 9:00 am. The daily dose will be 101.25 mg in men and 20.25 mg in women. Placebo gel will be administered within 24 hours after inclusion for a period of 28 days or until hospital discharge. For patients discharged from ICU before day 28, Placebo gel will be administered in hospital wards to complete the 28 days of
Physical performance
"Physical performance at 3, 6 months and 1 year after ICU admission~6 minute walk distance 3 months after ICU admission, at 6 months and at 1 year 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"
Muscle strength
"Muscle strength at ICU discharge at 3, 6 months and 1 year after ICU admission~Handgrip: Kg and percent of the predicted force Medical Research Council testing (MRC)"
Muscular mass
"Muscular mass at 3, 6 months and 1 year after ICU admission~Mid-arm muscle circumference (MAMC)"
Test: Functional status
"Functional status at 3, 6 months and 1 year after ICU admission~• Composite score of 11 items of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL)"
Oxygen muscular consumption
"Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission~Ventilation free days at day 28 Length of stay in ICU Length of stay in hospital Mortality rate at day 28 Mortality rate at day 90 ICU mortality rate Hospital mortality rate"
RECRUITING
Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux, Nantes
NOT_YET_RECRUITING
Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin, Bordeaux
RECRUITING
Service d'Anesthésie et Réanimation Centre Jean-Perrin, Clermont-Ferrand
RECRUITING
Service de Médecine Intensive et Réanimation (MIR), CHU Clermont-Ferrand, Clermont-Ferrand
RECRUITING
Service de Médecine Intensive et de Réanimation CHD La Roche sur Yon, La Roche-sur-Yon
University Hospital, Clermont-Ferrand
OTHER