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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Milena MD Andonova
- Número de teléfono: +38615228123
- Correo electrónico: milena.andonova@kclj.si
Ubicaciones de estudio
-
-
-
Ljubljana, Eslovenia, 1000
- University Medical Centre Ljubljana
-
Contacto:
- Milena MD Andonova
- Número de teléfono: +38615228123
- Correo electrónico: milena.andonova@kclj.si
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biocompatibility markers (C3a, PF4, TAT)
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Beta-2 microglobulin removal
Periodo de tiempo: 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
Periodo de tiempo: after 30 minutes of dialysis
|
instantaneous urea clearance after 30 minutes
|
after 30 minutes of dialysis
|
|
p-cresyl sulfat removal
Periodo de tiempo: 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
Periodo de tiempo: During the 4-hour hemodiafiltration procedure
|
During citrate anticoagulation procedure
|
During the 4-hour hemodiafiltration procedure
|
|
Extracorporeal circuit clotting score
Periodo de tiempo: At the end of hemodiafiltration procedure.
|
At the end of hemodiafiltration procedure.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia Renal Crónica
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia renal
- Insuficiencia Renal Crónica
- Carbohidratos
- Glicosaminoglicanos
- Polisacáridos
- Heparina
Otros números de identificación del estudio
- BIOCOMP-HDF
- 0120-610/2025-2711-5 (Identificador de registro: Republic of Slovenia National Medical Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .