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Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients

A Prospective Observational Study of Multimodal Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07607236
Acronym
KT-SARC
Enrollment
140
Registered
2026-05-26
Start date
2026-05-30
Completion date
2028-01-30
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Muscle Wasting, Sarcopenia

Keywords

Muscle Ultrasound, Bioelectrical Impedance Analysis, BIA-SMI, Kidney Transplant Recipient, Muscle Mass, Frailty, Prospective Cohort

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMuscle Ultrasound

Multimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.From baseline to 1 year after kidney transplantationDiagnostic 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).

Secondary

MeasureTime frameDescription
Change in Muscle Thickness Measured by UltrasoundFrom baseline to 1 year after kidney transplantationLongitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.
Change in Muscle Cross-Sectional Area Measured by UltrasoundFrom baseline to 1 year after kidney transplantationLongitudinal changes in muscle cross-sectional area measured by ultrasound from baseline to 1 year after kidney transplantation.
Change in Muscle Echogenicity Measured by UltrasoundFrom baseline to 1 year after kidney transplantationLongitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.

Countries

China

Contacts

CONTACTYifu Hou, MD, PhD
houyifu0726@foxmail.com+86-18980732072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026