- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07607236
Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients (KT-SARC)
A Prospective Observational Study of Multimodal Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients
This is a single-center prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Adult patients undergoing kidney transplantation will undergo both muscle ultrasound and bioelectrical impedance analysis (BIA) at predefined time points before and after transplantation.
The primary objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment, including its correlation and agreement with BIA-derived skeletal muscle index (BIA-SMI), as well as its diagnostic accuracy. Secondary objectives include describing the longitudinal changes in sarcopenia prevalence and muscle-related parameters from the pre-transplant period to 1 year after transplantation.
The study aims to provide evidence for a convenient, noninvasive, radiation-free, and reliable method for sarcopenia assessment in kidney transplant recipients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sarcopenia is highly prevalent among patients with end-stage renal disease and is associated with poor clinical outcomes. Although kidney transplantation may improve overall health status, perioperative stress, immunosuppressive therapy, and postoperative metabolic changes may influence muscle mass and function. Reliable assessment of sarcopenia in kidney transplant recipients remains clinically important.
Current methods for sarcopenia assessment include computed tomography (CT), dual-energy X-ray absorptiometry (DXA), and bioelectrical impedance analysis (BIA). However, CT and DXA are limited by radiation exposure, cost, and accessibility, while BIA may be affected by changes in hydration status, especially in transplant recipients. Muscle ultrasound is a portable, radiation-free, and bedside-available imaging modality that may provide a practical alternative for muscle assessment.
This prospective observational study will enroll adult kidney transplant recipients at Sichuan Provincial People's Hospital. Participants will undergo multimodal muscle ultrasound and BIA examinations at predefined perioperative time points. Ultrasound parameters will include muscle thickness, cross-sectional area, and echogenicity.
The primary study objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard. Correlation analysis, intraclass correlation coefficients, Bland-Altman analysis, and receiver operating characteristic (ROC) curve analysis will be performed to evaluate agreement and diagnostic accuracy.
Secondary objectives include evaluating longitudinal changes in muscle-related parameters and sarcopenia prevalence from the pre-transplant period to 1 year after kidney transplantation. Linear mixed-effects models or generalized estimating equations will be used to analyze temporal trends.
This study aims to establish muscle ultrasound as a practical and reliable tool for sarcopenia assessment in kidney transplant recipients and to improve understanding of perioperative muscle changes after transplantation.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yifu Hou, MD, PhD
- Número de teléfono: +86-18980732072
- Correo electrónico: houyifu0726@foxmail.com
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610072
- Sichuan Provincial People's Hospital
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Contacto:
- Yifu Hou, MD, PhD
- Número de teléfono: +86-18980732072
- Correo electrónico: houyifu0726@foxmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients scheduled to undergo kidney transplantation
- Ability to undergo muscle ultrasound and bioelectrical impedance analysis (BIA)
- Ability to provide written informed consent
Exclusion Criteria:
- Patients with severe limb deformity or conditions preventing muscle ultrasound assessment
- Patients with implanted electronic devices contraindicating BIA assessment
- Inability to complete study assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Kidney Transplant Recipients
Adult kidney transplant recipients undergoing prospective assessment of sarcopenia using multimodal muscle ultrasound and bioelectrical impedance analysis (BIA).
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Multimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area under the receiver operating characteristic (ROC) curve of muscle ultrasound for detecting sarcopenia using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard.
Periodo de tiempo: From baseline to 1 year after kidney transplantation
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Diagnostic performance of multimodal muscle ultrasound for sarcopenia assessment using BIA-derived skeletal muscle index (BIA-SMI) as the reference standard, including receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
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From baseline to 1 year after kidney transplantation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Muscle Thickness Measured by Ultrasound
Periodo de tiempo: From baseline to 1 year after kidney transplantation
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Longitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.
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From baseline to 1 year after kidney transplantation
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Change in Muscle Cross-Sectional Area Measured by Ultrasound
Periodo de tiempo: From baseline to 1 year after kidney transplantation
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Longitudinal changes in muscle cross-sectional area measured by ultrasound from baseline to 1 year after kidney transplantation.
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From baseline to 1 year after kidney transplantation
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Change in Muscle Echogenicity Measured by Ultrasound
Periodo de tiempo: From baseline to 1 year after kidney transplantation
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Longitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.
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From baseline to 1 year after kidney transplantation
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-304
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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