Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill

PHASE2RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

April 1, 2027

Conditions
Critical Illness
Interventions
DRUG

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

DRUG

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

DIAGNOSTIC_TEST

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"

DIAGNOSTIC_TEST

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)"

DIAGNOSTIC_TEST

Muscular mass

"Muscular mass at 3, 6 months and 1 year after ICU admission~Mid-arm muscle circumference (MAMC)"

DIAGNOSTIC_TEST

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)"

DIAGNOSTIC_TEST

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"

Trial Locations (5)

44000

RECRUITING

Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux, Nantes

Unknown

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

All Listed Sponsors
lead

University Hospital, Clermont-Ferrand

OTHER