Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07607236

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Ultrasound

Diagnostic Test

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

Primary outcomes

  1. 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.

    Time frame: From baseline to 1 year after kidney transplantation

    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).

Secondary outcomes

  1. Change in Muscle Thickness Measured by Ultrasound

    Time frame: From baseline to 1 year after kidney transplantation

    Longitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.

  2. Change in Muscle Cross-Sectional Area Measured by Ultrasound

    Time frame: From baseline to 1 year after kidney transplantation

    Longitudinal changes in muscle cross-sectional area measured by ultrasound from baseline to 1 year after kidney transplantation.

  3. Change in Muscle Echogenicity Measured by Ultrasound

    Time frame: From baseline to 1 year after kidney transplantation

    Longitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Yifu Hou, MD, PhD

CONTACT

[email protected]

+86-18980732072

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: KT-SARC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.