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Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration (CITRA-HDF)

27. mai 2026 oppdatert av: Milena Andonova, University Medical Centre Ljubljana

Efficiency and Biocompatibility of Postdilution Hemodiafiltration Using Different Anticoagulation Methods: A Randomized Crossover Clinical Trial

This randomized crossover clinical trial will compare regional citrate anticoagulation (RCA) and standard heparin anticoagulation (HA) during postdilution hemodiafiltration (HDF) in chronic dialysis patients with end-stage kidney disease.

The primary aim of the study is to evaluate biocompatibility during HDF by measuring markers of complement activation (C3a), platelet activation (PF4), and coagulation activation (thrombin-antithrombin complex, TAT).

Secondary aims include comparison of solute removal efficiency, including beta-2 microglobulin, phosphate, and urea removal, as well as assessment of citrate, calcium, and magnesium kinetics during citrate anticoagulation.

Twenty adult chronic dialysis patients will undergo two study HDF procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation with a one-week interval between procedures.

The study aims to improve understanding of the effects of anticoagulation methods on hemodiafiltration biocompatibility and dialysis efficiency and may contribute to optimization of citrate anticoagulation protocols in chronic hemodiafiltration patients.

Studieoversikt

Detaljert beskrivelse

Hemodiafiltration (HDF) is an advanced renal replacement therapy combining diffusion and convection, allowing improved removal of middle and larger molecular weight solutes compared with standard hemodialysis. During extracorporeal circulation, blood contact with artificial membranes and tubing activates complement, platelets, leukocytes, and coagulation pathways, requiring anticoagulation during the procedure.

Unfractionated heparin is routinely used for anticoagulation during HDF. Regional citrate anticoagulation (RCA) is mainly used in patients at increased bleeding risk. Previous studies in hemodialysis have suggested that citrate anticoagulation may improve biocompatibility because many blood-material interactions are calcium- and magnesium-dependent. However, biocompatibility during HDF using citrate versus heparin anticoagulation has not been systematically investigated.

This prospective randomized crossover clinical trial will include 20 adult patients with end-stage kidney disease receiving maintenance postdilution hemodiafiltration three times weekly. Patients will be randomized to one of two anticoagulation sequences: heparin-citrate or citrate-heparin. Each participant will undergo two study HDF procedures separated by a one-week interval.

During heparin anticoagulation, unfractionated heparin will be administered according to body weight using standard clinical protocols. During citrate anticoagulation, 8% trisodium citrate infusion and calcium-free dialysate will be used, with continuous calcium chloride substitution adjusted according to ionized calcium levels.

Biocompatibility markers including complement activation marker C3a, platelet factor 4 (PF4), thrombin-antithrombin complex (TAT), blood cell counts, and coagulation parameters will be assessed before HDF, after 15 minutes, and at the end of the procedure.

Dialysis efficiency will be evaluated by measurement of reduction ratios and total removal of beta-2 microglobulin, phosphate, and urea using partial dialysate collection methodology.

Additional secondary outcomes include assessment of citrate, calcium, and magnesium kinetics during RCA-HDF, visual clotting score evaluation of the extracorporeal circuit, and optimization of citrate anticoagulation protocols during postdilution HDF.

The study may contribute to improved understanding of anticoagulation-related biocompatibility during HDF and support wider evidence-based use of regional citrate anticoagulation in chronic dialysis patients.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana
        • 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

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older
  • End-stage kidney disease requiring maintenance postdilution hemodiafiltration
  • Stable chronic hemodialysis treatment three times weekly
  • Functional arteriovenous fistula

Exclusion Criteria:

  • Therapeutic anticoagulation therapy
  • Dual antiplatelet therapy
  • Significant coagulopathy
  • Active bleeding
  • Acute kidney injury

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Citrate anticoagulation
Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements
Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.
Aktiv komparator: Heparin anticoagulation
Participants will undergo postdilution hemodiafiltration using standard unfractionated heparin anticoagulation according to routine clinical protocol.
Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Biocompatibility markers (C3a, PF4, TAT)
Tidsramme: Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.
Comparison of complement activation marker C3a, platelet factor 4 (PF4), and thrombin-antithrombin complex (TAT) concentrations between citrate and heparin anticoagulation during postdilution hemodiafiltration.
Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Beta-2 microglobulin removal
Tidsramme: Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
Reduction ratio and total removal of beta-2 microglobulin during hemodiafiltration.
Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
instantaneous urea clearance after 30 minutes
Tidsramme: after 30 minutes of dialysis
instantaneous urea clearance after 30 minutes
after 30 minutes of dialysis
p-cresyl sulfat removal
Tidsramme: P-cresyl sulfat removal before, during and to the end of procedure
P-cresyl sulfat removal before, after 30 minutes and at the end of the procedure
P-cresyl sulfat removal before, during and to the end of procedure
Ionized calcium kinetics
Tidsramme: During the 4-hour hemodiafiltration procedure
During citrate anticoagulation procedure
During the 4-hour hemodiafiltration procedure
Extracorporeal circuit clotting score
Tidsramme: At the end of hemodiafiltration procedure.
At the end of hemodiafiltration procedure.

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)

5. juni 2026

Primær fullføring (Antatt)

15. desember 2026

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

16. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. 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 privacy and institutional data protection regulations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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