Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill
NCT ID: NCT05825092
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
600 participants
INTERVENTIONAL
2023-07-21
2027-04-01
Brief Summary
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Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage. During acute phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid release. Under stress conditions, protein synthesis cannot match the increased rate of muscle proteolysis because of a state of anabolism resistance, which limits uptake of amino acids into muscles.
Hypermetabolism results in a significant loss of lean body mass with an impact on weaning from the ventilator and muscle recovery. Functional disability can be long term sometimes with no full return to normal.
In critically ill patients, severe and persistent testosterone deficiency is very common and is observed early after Intensive Care Unit (ICU) admission. This acquired hypogonadism promotes the persistent loss of skeletal muscle protein and is related to poor outcome.
Administration of testosterone induces skeletal muscle fiber hypertrophy and decreases protein breakdown in healthy young men. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in hypogonadal men and women and can improve physical performance. Testosterone administration in burned patients reduces protein breakdown and increases protein synthesis efficiency. Oxandrolone, a synthetic testosterone analogue, reduces body mass and nitrogen loss and accelerates healing in burned patients. Trials in critically ill unburned patients failed to demonstrate any effect on clinical outcome but the studies were underpowered to detect a difference.
Transdermal gel testosterone is the preferred route of administration for achieving steady serum testosterone concentrations as compared to oral and intramuscular formulations.
Intramuscular injection induces strong fluctuations of testosterone plasma concentrations and can cause haematoma in patients with coagulation disorders, a common condition in ICUs. Several studies have raised the concern that testosterone administration could increase the risk of cardiovascular disease events. However, in a recent meta-analysis, no significant effects on cardiovascular risk were observed with either injected or transdermal testosterone supplementation in men, and the French National Agency for Medicines (ANSM) recently reported that drugs containing testosterone were not associated with an increased risk of cardiovascular events.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AndroGel® 1.62%
AndroGel® will be applied daily to the upper arms/shoulders. 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
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
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
Placebo gel will be the same gel without testosterone
Placebo gel will be applied daily to the upper arms/shoulders. 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 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test (b-HCG) in female patient of childbearing potential
* Invasive mechanical ventilation expected to be required for more than 48 hours
* Written informed consent obtained from the patient or his/her legal representative
* Social security cover
* Contraception
* Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during treatment and for 7 months after the last treatment intake
* Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during treatment and for 4 months after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 4 months after the last treatment intake
Exclusion Criteria
* History of breast cancer
* Prostate cancer suspected or confirmed
* Breast cancer suspected or confirmed
* PSA (prostatic specific antigen) ≥ 4 ng/ml
* ICU length of stay \> 120 h before enrollment
* Moribund
* Pre-existing illness with a life expectancy of \<6 months
* Recent intracranial or spinal cord injury (\< 1 month)
* Recent haemorrhagic or ischemic stroke (\< 1 month)
* Neuromuscular disease
* Cardiac arrest in non-shockable rhythm
* Preexistent cognitive impairment or language barrier
* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not excluded)
* Documented allergy to testosterone
* Age \> 80 years
* Pregnancy
* Breast feeding
18 Years
79 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Konstantinos BACHOUMAS, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital, La Roche sur Yon
Bertrand SOUWEINE, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Clermont-Ferrand
Locations
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Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin
Bordeaux, , France
Service d'Anesthésie et Réanimation Centre Jean-Perrin
Clermont-Ferrand, , France
Service de Médecine Intensive et Réanimation (MIR), CHU Clermont-Ferrand
Clermont-Ferrand, , France
Service de Médecine Intensive et de Réanimation CHD La Roche sur Yon
La Roche-sur-Yon, , France
Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHRC N 2018 BACHOUMAS
Identifier Type: -
Identifier Source: org_study_id
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