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| ID | Type | Description | Link |
|---|---|---|---|
| 0120-610/2025-2711-5 | Registry Identifier | Republic of Slovenia National Medical Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrate anticoagulation | Experimental | Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements |
|
| Heparin anticoagulation | Active Comparator | Participants will undergo postdilution hemodiafiltration using standard unfractionated heparin anticoagulation according to routine clinical protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional citrate anticoagulation | Drug | Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-2 microglobulin removal | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milena MD Andonova | Contact | +38615228123 | milena.andonova@kclj.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
Individual participant data will not be publicly available due to privacy and institutional data protection regulations.
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Participants will undergo two study hemodiafiltration procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation, with a one-week interval between procedures.
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| Unfractionated heparin | Drug | Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration. |
|
instantaneous urea clearance after 30 minutes
| after 30 minutes of dialysis |
| p-cresyl sulfat removal | 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 | During citrate anticoagulation procedure | During the 4-hour hemodiafiltration procedure |
| Extracorporeal circuit clotting score | At the end of hemodiafiltration procedure. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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