Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients
Hypermetabolism in ICU · Loss of Muscle Mass · Functional Disability After ICU · ICU Acquired Hypogonadism · Treatment With Testosterone Gel in ICU
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 79 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 30 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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 may 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 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, decreases protein breakdown in healthy young men and burned patients. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in young and older hypogonadal men and women and can improve physical performance.
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Type of trial
TestICUs-1 is a single center open-label parallel randomized controlled study phase II assessing the efficacy of testosterone gel to correct low testosterone serum levels associated with ICU acquired hypogonadism in mechanically ventilated patients with shock. TestICUs-1 will be conducted in the 10-bed medical ICU of the university hospital of Clermont-Ferrand. Study drug is Androgel® 1.62 mg/L approved by the ANSM for the treatment of hypogonadism in men containing 1.62% of testosterone.
Category of research Research involving human subjects aimed at assessing the efficacy of and safety to drug.
Study phase
- II/ Feasibility
- Technology Readiness Level : 7 B
A study assessing the efficacy of a multimodal strategy including treatment with testosterone gel, (75 mg/day in men and 25 mg/day in women) in improving physical activity in hemodialysis patients is in progress (Americano PHRC N 2012, AE Heng).
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- \- Males and females aged over 18 years receiving invasive mechanical ventilation
- Invasive mechanical ventilation expected to be required for more than 48 hours
- Treatment with vasoactive drugs
- Written informed consent obtained from the legal representative
- Social security cover
Exclusion Criteria:
- \- History of prostate or breast cancer, prostatic specific antigen (PSA) ≥ 4 ng/ml
- ICU length of stay \> 72 h before enrollment
- Moribund defined as having a score SAPS II \> 75 12 hours after admission
- Pre-existing illness with a life expectancy of \<6 months
- Cardiac arrest
- Preexistent cognitive impairment or language barrier
- Acute intracranial or spinal cord injury
- Acute hemorrhagic or ischemic stroke
- Neuromuscular disease (Guillain-Barré, myasthenia)
- 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 or breast feeding
- Patient on judicial protection
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Intervention
AndroGel® AndroGel 16.2 mg/L will be applied to upper arms or shoulders once a day at 9:00 am to dry and intact skin for a period of 28 days or until ICU discharge. The daily dose 101.25 mg in men and 20.25 mg in women
Drug: AndroGel 16.2 mg/L
Control
In the control group, AndroGel will not be administered.
AndroGel 16.2 mg/L DRUG
Testosterone gel 1.62 % will be applied to upper arms or shoulders once a day at 9:00 am to dry and intact skin for a period of 28 days or until ICU discharge. The daily dose 101.25 mg in men and 20.25 mg in women.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Pourcentage of patients with normal median value of serum total testosterone
Plazo: day 4 to day 14
Pourcentage of patients with median value of serum total testosterone collected from blood samples at day 4, 7, 10, 14 higher than 280 ng/dl in men and 12 ng/dl in women.
Medidas secundarias
Proportion of patients with normal median free testosterone serum values
Plazo: day 4 to day 14
Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women
Proportion of patients with normal median serum values of bioavailable testosterone
Plazo: day 4 to day 14
Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women
Nitrogen balance
Plazo: daily from day 1 to day 14
Daily and cumulative nitrogen balance from day 1 to extubation
Physical performance
Plazo: day 14, 1month and 3 months after ICU discharge
Physical performance by Six-minute walk test (6MWT)
Muscle strength
Plazo: at ICU discharge, 1month and 3 months after ICU discharge
Muscle strength by MRC (Medical Research Scale)
Near Infrared Spectroscopy
Plazo: at 14 days
Near Infrared Spectroscopy by NIRS test
Muscular mass
Plazo: at ICU discharge and 1month after ICU discharge
Muscular mass by L3 computed tomography
Lung function
Plazo: at 1 and 3 months after ICU discharge
Lung function by spirometry
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Chu Clermont-FerrandClermont-Ferrand, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- University Hospital, Clermont-Ferrand
- Inicio del estudio
- 27 jun 2019 Real
- Finalización primaria
- 1 nov 2023 Real
- Finalización del estudio
- 1 nov 2023 Real
- Primera publicación
- 19 sept 2018 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026