Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration (CITRA-HDF)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Milena MD Andonova
- Numéro de téléphone: +38615228123
- E-mail: milena.andonova@kclj.si
Lieux d'étude
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Ljubljana, Slovénie, 1000
- University Medical Centre Ljubljana
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Contact:
- Milena MD Andonova
- Numéro de téléphone: +38615228123
- E-mail: milena.andonova@kclj.si
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Citrate anticoagulation
Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements
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Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.
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Comparateur actif: Heparin anticoagulation
Participants will undergo postdilution hemodiafiltration using standard unfractionated heparin anticoagulation according to routine clinical protocol.
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Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Biocompatibility markers (C3a, PF4, TAT)
Délai: Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.
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Comparison of complement activation marker C3a, platelet factor 4 (PF4), and thrombin-antithrombin complex (TAT) concentrations between citrate and heparin anticoagulation during postdilution hemodiafiltration.
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Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Beta-2 microglobulin removal
Délai: Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
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Reduction ratio and total removal of beta-2 microglobulin during hemodiafiltration.
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Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.
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instantaneous urea clearance after 30 minutes
Délai: after 30 minutes of dialysis
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instantaneous urea clearance after 30 minutes
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after 30 minutes of dialysis
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p-cresyl sulfat removal
Délai: P-cresyl sulfat removal before, during and to the end of procedure
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P-cresyl sulfat removal before, after 30 minutes and at the end of the procedure
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P-cresyl sulfat removal before, during and to the end of procedure
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Ionized calcium kinetics
Délai: During the 4-hour hemodiafiltration procedure
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During citrate anticoagulation procedure
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During the 4-hour hemodiafiltration procedure
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Extracorporeal circuit clotting score
Délai: At the end of hemodiafiltration procedure.
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At the end of hemodiafiltration procedure.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Insuffisance rénale chronique
- Conditions pathologiques, signes et symptômes
- Insuffisance rénale
- Insuffisance rénale chronique
- Glucides
- Glycosaminoglycanes
- Polysaccharides
- Héparine
Autres numéros d'identification d'étude
- BIOCOMP-HDF
- 0120-610/2025-2711-5 (Identificateur de registre: Republic of Slovenia National Medical Ethics Committee)
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Description du régime IPD
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