Skip to content

TestICUs : Effects of early testosterone gel administration on physical performance in the critically ill: a randomised double blind clinical trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519156-93-00
Acronym
PHRC N2018 BACHOUMAS
Enrollment
600
Registered
2024-12-30
Start date
2023-07-21
Completion date
Unknown
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive mechanical ventilation expected to be required for more than 48 hours

Brief summary

• Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters

Detailed description

Physical performance 3, 6 months and 1 year after ICU admission : 6 MWD at 6 months and 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 on ICU discharge at 3, 6 months and 1 year after ICU admission: - Handgrip: Kg and percentage of the predicted force, - MRC, 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, Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission, Ventilation free days at day 28, 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 events, - Obstructive sleep apnea, - Increase in hemoglobin, hematocrit and red blood cells counts, - Alopecia, urticaria, acne, erythema, - Vertigo, paresthesia, - Depression, anxiety, - Gynaecomastia, - Oedema, weight gain, - insulin requirements, - Fractures

Interventions

DRUGTESTOGEL
DRUG2 mg/g
DRUGgel

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters

Secondary

MeasureTime frame
Physical performance 3, 6 months and 1 year after ICU admission : 6 MWD at 6 months and 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 on ICU discharge at 3, 6 months and 1 year after ICU admission: - Handgrip: Kg and percentage of the predicted force, - MRC, 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, Oxygen muscular consumption at ICU discharge and at 3 months after ICU admission, Ventilation free days at day 28, 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 events, - Obstructive sleep apnea, - Increase in hem

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026