This clinical trial is focused on patients who are critically ill and require invasive mechanical ventilation for more than 48 hours. The study is investigating the effects of a treatment using a gel called ANDROGEL, which contains the active substance testosterone. Testosterone is a hormone that plays a key role in physical performance and muscle strength. The trial aims to see if applying this gel daily can improve physical performance three months after being admitted to the intensive care unit (ICU) compared to a placebo gel, which does not contain active ingredients.
Participants in the study will receive either the testosterone gel or the placebo gel for a period of up to 28 days. The study will monitor the physical performance of participants at different intervals: three months, six months, and one year after ICU admission. This will include tests like the six-minute walk distance test, which measures how far a person can walk in six minutes. The study will also look at muscle strength, muscle mass, and overall functional status over time. Additionally, the safety of the testosterone gel will be assessed by monitoring for any side effects such as high blood pressure, cardiovascular events, or changes in blood cell counts.
The purpose of this study is to determine if early administration of testosterone gel can help improve recovery and physical performance in critically ill patients. The trial will also track other outcomes such as the number of days patients are free from ventilation, the length of stay in the ICU and hospital, and mortality rates. The study is expected to continue until July 2027, with the goal of providing valuable insights into the potential benefits of testosterone treatment in this patient group.



France