Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSichuan Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with severe limb deformity or conditions preventing muscle ultrasound assessment
Patients with implanted electronic devices contraindicating BIA assessment
Inability to complete study assessments
Trial population
Adult kidney transplant recipients undergoing perioperative sarcopenia assessment at Sichuan Provincial People's Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Muscle Ultrasound
Diagnostic testMultimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Kidney Transplant Recipients1 intervention
Trial outcomes
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.
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).
Time frame
From baseline to 1 year after kidney transplantationSecondary outcomes
1
Change in Muscle Thickness Measured by Ultrasound
Longitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.
Time frame
From baseline to 1 year after kidney transplantation2
Change in Muscle Cross-Sectional Area Measured by Ultrasound
Longitudinal changes in muscle cross-sectional area measured by ultrasound from baseline to 1 year after kidney transplantation.
Time frame
From baseline to 1 year after kidney transplantation3
Change in Muscle Echogenicity Measured by Ultrasound
Longitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.
Time frame
From baseline to 1 year after kidney transplantationSponsors and contacts
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Source ClinicalTrials.gov
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