Critical IllnessPhase 2TestICUsNCT05825092
Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill
A Phase 2 study testing Androgel Topical Product, Physical performance and Muscle strength in people with Critical Illness, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial summary
Critically ill patients experience major insults that lead to increased protein catabolism. 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Androgel Topical Product, Physical performance and Muscle strength
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Jul 2023to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged over 18 years
- 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
Who cannot join
- History of prostate cancer
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Service de Medecine Intensive et Réanimation CHU de Bordeaux Hopital Pellegrin
Bordeaux
Alexandre BOYER, MD, alexandre.boyer@chu-bordeaux.fr
Alexandre BOYER, MD
- Recruiting
Service d'Anesthésie et Réanimation Centre Jean-Perrin
Clermont-Ferrand
Alexandre LAUTRETTE, alautrette@chu-clermontferrand.fr
Alexandre LAUTRETTE, MD, PhD
- Recruiting
Service de Médecine Intensive et Réanimation (MIR), CHU Clermont-Ferrand
Clermont-Ferrand
Claire DUPUIS, MD, cdupuis1@chu-clermontferrand.fr
Claire DUPUIS, MD
- Recruiting
Service de Médecine Intensive et de Réanimation CHD La Roche sur Yon
La Roche-sur-Yon
Konstantinos Bachoumas, MD, cbachoumas@gmail.com
Konstantinos Bachoumas, MD
- Recruiting
Service de Médecine Intensive et Réanimation CHU Nantes, Hôtel Dieux
Nantes, 44000
Jean Reignier, jean.reignier@chu-nantes.fr
Jean Reignier
About this study
Official title: Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial
Critically ill patients experience major insults that lead to increased protein catabolism.
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.
Read more
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.
- Conditions
- Critical Illness
- Being tested
- Androgel Topical Product, Placebo, Physical performance, Muscle strength, Muscular mass
- Keywords
- Critical ill patient, Physical performance, Testosterone
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgel Topical ProductDrug
Also called Androgel 1.62% Transdermal Gel
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
PlaceboDrug
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 performanceDiagnostic test
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 strengthDiagnostic test
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 massDiagnostic test
Muscular mass at 3, 6 months and 1 year after ICU admission
Mid-arm muscle circumference (MAMC)
Test: Functional statusDiagnostic test
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 consumptionDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| AndroGel® 1.62% | Active comparator | 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 Receives: Drug: Androgel Topical Product; Diagnostic Test: Physical performance; Diagnostic Test: Muscle strength; Diagnostic Test: Muscular mass; Diagnostic Test: Test: Functional status; Diagnostic Test: Oxygen muscular consumption |
| Placebo gel will be the same gel without testosterone | Placebo comparator | 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 Receives: Drug: Placebo; Diagnostic Test: Physical performance; Diagnostic Test: Muscle strength; Diagnostic Test: Muscular mass; Diagnostic Test: Test: Functional status; Diagnostic Test: Oxygen muscular consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 6-minute-walk distance test (6MWD)
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
Measured: 3 months after ICU admission
Secondary outcomes (17)
the 6-minute-walk
Percentage of patients with 6 MWD at 6 months > 60% the distance walked in an age-matched and sex-matched control population
Measured: 6 months
the 6-minute-walk
Percentage of patients with 6 MWD at 1 year > 65% the distance walked in an age-matched and sex-matched control population
Measured: 1 year after ICU admission
Functional status with Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL)
11 items of Activities of Daily Living (ADL) and Instrumental
Activities of Daily Living (IADL):
Measured: at 3, 6 months and 1 year after ICU admission
Oxygen muscular consumption with NIRS test (Near Infrared Spectroscopy)
Low muscle oxidative capacity is associated with muscle dysfunction and exercise intolerance in COPD patients and may contribute to reduce physical activity and quality of life in these patients. Muscle maximal oxidative capacity can be evaluated by oxygen muscular consumption which will be measured by Near Infrared Spectroscopy (NIRS), during a series of short arterial occlusions in muscle quadriceps. Studies performed in healthy subjects showed a good agreement with high-resolution respirometry and phosphorus magnetic resonance spectroscopy (P-MRS) for assessing mitochondrial respiratory capacity. In COPD patients, NIRS technique was feasible and well tolerated.
Measured: 48 hours after intensive care unit (ICU) admission and 3 months after ICU admission
Muscular mass with MAMC (Mid-arm muscle circumference):
Mid-arm muscle circumference (MAMC) : MAMC (Mid-arm muscle circumference): MAMC is calculated using the following formula:
MAMC = mid-arm circumference - (3.14 × triceps skinfold thickness). The mid-arm circumference is measured using a standard flexible measuring tape on the left upper arm, at the mid-point between the olecranon process of the shoulder and the acromion, with the subject in a seated position. The triceps skinfold thickness is measured using a calibrated skinfold caliper (range 0.00- 50.00 mm; minimum graduation 0.2 mm) (85).
Measured: at 3, 6 months and 1 year after ICU admission
the Short Physical Performance Battery (SPPB)
Percentage of patients with Short Physical Performance Battery < 10 at 3 months: The SPPB represents the sum of results from three component tests of functional relevance: standing balance, 4-meter gait speed (4MGS), and fiverepetition sit-to-stand motion (5STS). Each component is scored based on a subscale, and the three subscores are added to obtain a summary score. The SPPB is a high-level physical function outcome as it examines gait speed, balance control and sit-to-stand repetitions. It has been commonly used in COPD patients. In critical ill patients, the SPPB may be more appropriate as a measure in the post ICU setting in the acute hospital wards or post hospital discharge.
Measured: 3, 6 months and 1 year after ICU admission
Physical component of Medical Outcomes Study 36 Item Short Form Health (SF36)
Physical component of SF 36 (Medical Outcomes Study 36 Item Short Form Health):
The physical component of SF 36 is a commonly used and well validated instrument in critical ill patients. The SF 36 has demonstrated reliability, validity and responsiveness and is recommended in ICU populations.
Measured: 3, 6 months and 1 year after ICU admission
Muscle strength by Handgrip test
Kg and percent of the predicted force: Hand-grip strength (HGS) is a manual muscle test that enables measurement of force using a calibrated device. It is reliable, rapid and simple and can serve as a surrogate for global strength. Normative data are available. HGS has been commonly used in critical ill patients.
Measured: 48 hours after ICU admission, at 3, 6 months and 1 year after ICU admission
Muscle strength by Medical Research Council (MRC) score
MRC has been routinely used in critical care research to screen for muscle weakness. It classifies muscle contraction on a 0-5 point ordinal scale. Six muscle groups will be assessed bilaterally.
Measured: at 3, 6 months and 1 year after ICU admission
Ventilation free days
Number of day without ventilation
Measured: at day 28
Length of stay in the ICU
Number of date between ICU admission and ICU discharge
Measured: 48 hours after ICU admission
Length of stay in hospital
Number of date between ICU admission and hospital discharge
Measured: at hospital discharge, an average of 1 month
Mortality rate at day 28
rate of patient included in the study and died at day 28
Measured: at day 28
Mortality rate at day 90
rate of patient included in the study and died at day 90
Measured: at day 90
ICU mortality rate
rate of patient included in the study and died at ICU discharge
Measured: 48 hours after ICU admission
Hospital mortality rate
rate of patient included in the study and died at hospital discharge
Measured: at hospital discharge, an average of 1 month
Nombers of adverses events
Safety of testosterone gel
Measured: from day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start21 Jul 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, phase II, multi-centre, double blind, randomised, controlled, parallel group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantinos BACHOUMAS, MD, Principal investigator, Centre Hospitalier Departemental VendeeBertrand SOUWEINE, MD, PhD, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825092
- Sponsor's protocol ID
- PHRC N 2018 BACHOUMAS
- Acronym
- TestICUs
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05825092
- Acronym / sponsor ID
- TestICUs / PHRC N 2018 BACHOUMAS
- Conditions
- Critical Illness
- Keywords
- Critical ill patient, Physical performance, Testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critically ill patients experience major insults that lead to increased protein catabolism.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, phase II, multi-centre, double blind, randomised, controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| AndroGel® 1.62% | Active comparator | Drug: Androgel Topical Product, Diagnostic Test: Physical performance, Diagnostic Test: Muscle strength, Diagnostic Test: Muscular mass, Diagnostic Test: Test: Functional status, Diagnostic Test: Oxygen muscular consumptionAndroGel® 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 |
| Placebo gel will be the same gel without testosterone | Placebo comparator | Drug: Placebo, Diagnostic Test: Physical performance, Diagnostic Test: Muscle strength, Diagnostic Test: Muscular mass, Diagnostic Test: Test: Functional status, Diagnostic Test: Oxygen muscular consumptionPlacebo 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females aged over 18 years
- 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
Key exclusion criteria (18 listed)
- History of prostate cancer
- History of breast cancer
- Prostate cancer suspected or confirmed
- Breast cancer suspected or confirmed
- PSA (prostatic specific antigen) ≥ 4 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgel Topical ProductAlso: Androgel 1.62% Transdermal GelAndroGel® 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 | AndroGel® 1.62% |
| PlaceboPlacebo 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 | Drug | Placebo gel will be the same gel without testosterone |
| Physical performancePhysical 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 | AndroGel® 1.62%, Placebo gel will be the same gel without testosterone |
| Muscle strengthMuscle 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 | AndroGel® 1.62%, Placebo gel will be the same gel without testosterone |
| Muscular massMuscular mass at 3, 6 months and 1 year after ICU admission Mid-arm muscle circumference (MAMC) | Diagnostic test | AndroGel® 1.62%, Placebo gel will be the same gel without testosterone |
| Test: Functional statusFunctional 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 | AndroGel® 1.62%, Placebo gel will be the same gel without testosterone |
| Oxygen muscular consumptionOxygen 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 | Diagnostic test | AndroGel® 1.62%, Placebo gel will be the same gel without testosterone |
Primary outcome
the 6-minute-walk distance test (6MWD)
Time frame: 3 months after ICU admission
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
17 secondary outcomes
the 6-minute-walk
Time frame: 6 months
the 6-minute-walk
Time frame: 1 year after ICU admission
Functional status with Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL)
Time frame: at 3, 6 months and 1 year after ICU admission
Oxygen muscular consumption with NIRS test (Near Infrared Spectroscopy)
Time frame: 48 hours after intensive care unit (ICU) admission and 3 months after ICU admission
Muscular mass with MAMC (Mid-arm muscle circumference):
Time frame: at 3, 6 months and 1 year after ICU admission
the Short Physical Performance Battery (SPPB)
Time frame: 3, 6 months and 1 year after ICU admission
Physical component of Medical Outcomes Study 36 Item Short Form Health (SF36)
Time frame: 3, 6 months and 1 year after ICU admission
Muscle strength by Handgrip test
Time frame: 48 hours after ICU admission, at 3, 6 months and 1 year after ICU admission
Muscle strength by Medical Research Council (MRC) score
Time frame: at 3, 6 months and 1 year after ICU admission
Ventilation free days
Time frame: at day 28
Length of stay in the ICU
Time frame: 48 hours after ICU admission
Length of stay in hospital
Time frame: at hospital discharge, an average of 1 month
Mortality rate at day 28
Time frame: at day 28
Mortality rate at day 90
Time frame: at day 90
ICU mortality rate
Time frame: 48 hours after ICU admission
Hospital mortality rate
Time frame: at hospital discharge, an average of 1 month
Nombers of adverses events
Time frame: from day 1 to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos BACHOUMAS, MD principal investigator
Centre Hospitalier Departemental Vendee
Bertrand SOUWEINE, MD, PhD study director
University Hospital, Clermont-Ferrand
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgel Topical Product, Physical performance and Muscle strength in people with Critical Illness, run by University Hospital, Clermont-Ferrand at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 6-minute-walk distance test (6MWD) (time frame: 3 months after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.