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Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients (KT-SARC)

19. mai 2026 oppdatert av: Lingai Pan, Sichuan Provincial People's Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina, 610072
        • Sichuan Provincial People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult kidney transplant recipients undergoing perioperative sarcopenia assessment at Sichuan Provincial People's Hospital.

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Kidney Transplant Recipients
Adult kidney transplant recipients undergoing prospective assessment of sarcopenia using multimodal muscle ultrasound and bioelectrical impedance analysis (BIA).
Multimodal muscle ultrasound assessment performed for evaluation of sarcopenia in kidney transplant recipients.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
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).
From baseline to 1 year after kidney transplantation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Muscle Thickness Measured by Ultrasound
Tidsramme: From baseline to 1 year after kidney transplantation
Longitudinal changes in muscle thickness measured by ultrasound from baseline to 1 year after kidney transplantation.
From baseline to 1 year after kidney transplantation
Change in Muscle Cross-Sectional Area Measured by Ultrasound
Tidsramme: 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.
From baseline to 1 year after kidney transplantation
Change in Muscle Echogenicity Measured by Ultrasound
Tidsramme: From baseline to 1 year after kidney transplantation
Longitudinal changes in muscle echogenicity measured by ultrasound from baseline to 1 year after kidney transplantation.
From baseline to 1 year after kidney transplantation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. mai 2026

Primær fullføring (Antatt)

30. august 2027

Studiet fullført (Antatt)

30. januar 2028

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be publicly available due to institutional policy and participant privacy considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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