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Predicting Peritoneal Kt/Vurea Based on Single-Exchange Dialysate Effluent

16. juni 2026 oppdatert av: Peking University First Hospital

Development and Validation of a Prediction Model for Peritoneal Kt/Vurea Using Single-Exchange Dialysate Effluent in Patients Undergoing Peritoneal Dialysis

Background:

Peritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt/Vurea), a key indicator of small-solute clearance and treatment adequacy. The standard method for calculating peritoneal Kt/Vurea requires complete collection of 24-hour dialysate effluent, which is labor-intensive, time-consuming, and prone to errors arising from incomplete collection, inadequate mixing, and inaccurate sampling. Although proportional sampling from each exchange has been shown to yield results comparable to those obtained from complete 24-hour effluent collection, this approach still requires collection of all exchanges throughout the day. Previous studies have suggested that Kt/Vurea estimated from a single dialysate exchange may correlate with the standard measurement; however, these investigations were limited by small sample sizes and did not establish predictive equations. Therefore, a practical and accurate alternative for assessing peritoneal Kt/Vurea is still lacking.

Objective:

To develop and validate a prediction model for peritoneal Kt/Vurea based on single-exchange dialysate effluent in patients undergoing PD.

Methods:

This multicenter cross-sectional study will be conducted between 2026 and 2027 across four PD centers in China. Consecutive prevalent patients receiving manual PD will be screened for eligibility. Patients aged ≥14 years who have been receiving PD for at least one month will be included. Exclusion criteria comprise peritonitis or other acute complications within the preceding month, spontaneous ascites, inability to complete full dialysate collection during the study day, and refusal to provide informed consent. Demographic characteristics, primary kidney disease, comorbidities, and PD prescription parameters will be collected. On a designated study day, effluent from each dialysis exchange, 24-hour urine samples, and fasting blood samples will be obtained. The correlations between peritoneal Kt/Vurea calculated from individual exchanges and the reference peritoneal Kt/Vurea derived from complete 24-hour dialysate collection will be evaluated. Multivariable prediction models incorporating single-exchange effluent measurements and relevant clinical parameters will subsequently be developed and validated. Model performance will be assessed using measures of discrimination, calibration, and agreement with reference Kt/Vurea values.

Conclusions:

This study aims to establish and validate a simplified method for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent. If validated, the proposed model may substantially reduce the burden associated with 24-hour dialysate collection while maintaining adequate accuracy for routine assessment of PD adequacy.

Studieoversikt

Detaljert beskrivelse

This is a multicenter cross-sectional study aimed at developing and externally validating a prediction model for estimating peritoneal Kt/Vurea using single-exchange dialysate effluent in patients undergoing peritoneal dialysis.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study will be conducted between 2026 and 2027 across four peritoneal dialysis (PD) centers in China. All prevalent patients receiving manual PD will be screened for eligibility.

Beskrivelse

Inclusion Criteria:

Patients aged ≥14 years who have been receiving PD for at least one month.

Exclusion Criteria:

(1) peritonitis or other acute complications (e.g., severe infection or acute heart failure) within 1 month prior to enrollment; (2) spontaneous ascites; (3) inability to complete full collection of all dialysate effluent during the study dialysis day; (4) refusal or inability to provide written informed consent.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Accuracy of prediction of peritoneal Kt/Vurea using single-exchange dialysate effluent
Tidsramme: Baseline (single assessment)
Baseline (single assessment)

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)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Peritoneal Kt/Vurea

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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