Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
End-stage kidney disease requiring maintenance postdilution hemodiafiltration
Stable chronic hemodialysis treatment three times weekly
Functional arteriovenous fistula
Disqualifiers
Therapeutic anticoagulation therapy
Dual antiplatelet therapy
Significant coagulopathy
Active bleeding
Trial design
Design model
Crossover
Treatments tested in this trial
Regional citrate anticoagulation
DrugRegional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.
Unfractionated heparin
DrugStandard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Citrate anticoagulationExperimental treatment 1 intervention
Group B: Heparin anticoagulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biocompatibility markers (C3a, PF4, TAT)
Comparison of complement activation marker C3a, platelet factor 4 (PF4), and thrombin-antithrombin complex (TAT) concentrations between citrate and heparin anticoagulation during postdilution hemodiafiltration.
Time frame
Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.Secondary outcomes
1
Beta-2 microglobulin removal
Reduction ratio and total removal of beta-2 microglobulin during hemodiafiltration.
Time frame
Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.2
instantaneous urea clearance after 30 minutes
instantaneous urea clearance after 30 minutes
Time frame
after 30 minutes of dialysis3
p-cresyl sulfat removal
P-cresyl sulfat removal before, after 30 minutes and at the end of the procedure
Time frame
P-cresyl sulfat removal before, during and to the end of procedure4
Ionized calcium kinetics
During citrate anticoagulation procedure
Time frame
During the 4-hour hemodiafiltration procedureSponsors and contacts
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Source ClinicalTrials.gov
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