- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yifu Hou, MD, PhD
- Telefonnummer: +86-18980732072
- E-mail: houyifu0726@foxmail.com
Studiesteder
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Sichuan
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Chengdu, Sichuan, Kina, 610072
- Sichuan Provincial People's Hospital
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Kontakt:
- Yifu Hou, MD, PhD
- Telefonnummer: +86-18980732072
- E-mail: houyifu0726@foxmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Muscle Thickness Measured by Ultrasound
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-304
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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