Study on the Effects of Testosterone Gel on Physical Performance in Critically Ill Patients Requiring Long-Term Mechanical Ventilation

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What is this study about?

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.

1 joining the study

Eligibility is confirmed based on criteria such as age over 18, a negative pregnancy test for women of childbearing potential, and the expectation of requiring mechanical ventilation for more than 48 hours.

Informed consent is obtained from the patient or their legal representative.

2 treatment phase

During the acute phase of critical illness, a daily administration of testosterone gel is provided.

The dosage is 101.25 mg for men and 20.25 mg for women, applied through the skin.

A placebo may be administered instead, as part of the study’s design.

3 monitoring and assessment

Physical performance is assessed 3 months after ICU admission using the 6-minute-walk distance test.

Additional assessments occur at 3, 6 months, and 1 year after ICU admission, including muscle strength, muscle mass, and functional status.

Safety of the testosterone gel is monitored, checking for side effects such as hypertension, cardiovascular events, and other potential issues.

4 follow-up evaluations

Further evaluations of physical performance, muscle strength, and functional status are conducted at 6 months and 1 year after ICU admission.

The study also tracks outcomes such as ventilation-free days, length of stay in the ICU and hospital, and mortality rates at various intervals.

Who Can Join the Study?

  • Participants must be males or females aged over 18 years.
  • Female participants who can have children must have a negative pregnancy test before joining the study.
  • Participants can have COVID-19 or not; both are eligible.
  • Participants must need invasive mechanical ventilation for more than 48 hours. This means they will need a machine to help them breathe for more than two days.
  • Participants or their legal representatives must provide written informed consent. This means they agree to join the study after understanding what it involves.
  • Participants must have social security cover. This is a form of insurance or government support for health care.
  • Female participants who can have children must agree to use a highly effective method of contraception during the study and for 7 months after the last treatment. Their male partners must also use effective contraception.
  • Male participants with female partners who can have children must agree to use a highly effective method of contraception during the study and for 4 months after the last treatment. Their female partners must also use effective contraception.

Who Cannot Join the Study?

  • If you are expected to need invasive mechanical ventilation for more than 48 hours, you cannot participate. This means if you need a machine to help you breathe for more than two days, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cznjgj Hsnbxilytao Vcunc Vichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
21.07.2023

Trial locations

Investigated drugs:

Testosterone Gel is being tested in this clinical trial to see if it can help improve physical performance in people who are critically ill. The trial is looking at how effective daily use of this gel is during the early stages of critical illness. The goal is to see if it can make a difference in how well patients perform physically three months after being admitted to the intensive care unit (ICU).

Investigated diseases:

Invasive Mechanical Ventilation – This is a medical procedure used to assist or replace spontaneous breathing when a person is unable to breathe on their own. It involves the use of a machine called a ventilator, which delivers air into the lungs through a tube inserted into the windpipe. The need for this procedure can arise from various conditions, such as severe respiratory distress or failure. Over time, patients may experience muscle weakness due to prolonged use of the ventilator. The process of weaning off the ventilator can be gradual, depending on the patient’s recovery and ability to breathe independently. Monitoring and support are essential to ensure the patient’s safety and comfort during this period.

Trial ID:
2024-519156-93-00
Protocol code:
PHRC N2018 BACHOUMAS
NCT ID:
NCT05825092
Trial Phase:
Therapeutic exploratory (Phase II)

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