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

27. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Slovenien
      • Ljubljana, Slovenien, 1000
        • University Medical Centre Ljubljana
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Citrate anticoagulation
Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements
Medicin: Regional citrate anticoagulation
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.
Medicin: Unfractionated heparin
Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

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Sponsor

University Medical Centre Ljubljana

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. juni 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BIOCOMP-HDF
  • 0120-610/2025-2711-5 (Registry Identifier: Republic of Slovenia National Medical Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly available due to privacy and institutional data protection regulations.

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