drugset / Trial / NCT07618858

Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration

NCT07618858

Not yet recruiting 20 enrolled University Medical Centre Ljubljana
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2026-06-05
Primary completion
2026-12-15
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Heparin Other / unclassified
Subject trisodium citrate Unknown 8 %