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Набор скоро начнётся NCT07618858

Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration

Без фазы С лечением End-Stage Kidney Disease Hemodiafiltration Chronic Hemodialysis Renal Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Regional citrate anticoagulation, Unfractionated heparin.
Кому может быть актуально
Состояния в реестре: End-Stage Kidney Disease, Hemodiafiltration, Chronic Hemodialysis, Renal Failure. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Словения
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Regional citrate anticoagulation
    Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.
  • Препарат Unfractionated heparin
    Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.

Первичные конечные точки

  • Biocompatibility markers (C3a, PF4, TAT) [Срок оценки: Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.]
Вторичные конечные точки (5)
  • Beta-2 microglobulin removal [Срок оценки: Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.]
  • instantaneous urea clearance after 30 minutes [Срок оценки: after 30 minutes of dialysis]
  • p-cresyl sulfat removal [Срок оценки: P-cresyl sulfat removal before, during and to the end of procedure]
  • Ionized calcium kinetics [Срок оценки: During the 4-hour hemodiafiltration procedure]
  • Extracorporeal circuit clotting score [Срок оценки: At the end of hemodiafiltration procedure.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Словения · 1 центр
  • University Medical Centre Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07618858 · BIOCOMP-HDF · 0120-610/2025-2711-5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗