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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
| NIER research group | UNKNOWN |
| University of Rochester | OTHER |
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This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses.
During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week.
During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells.
The study aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polysulfone dialyzer membrane | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun) |
|
| Asymmetric triacetate dialyzer membrane | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro) |
|
| Polymethyl methacrylate dialyzer membrane | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a polysulfone membrane | Device | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition | The primary endpoint will be the difference in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialyzer membrane used. | Over the course of 1 week (3 hemodialysis sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition | differences in leukocyte and platelet activation markers in blood samples and rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition; assessed by mean fluorescence intensity and the relative number of positive cells for the respective activation marker measured by flow cytometry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florine Janssens, Medical Doctor | Universitair Ziekenhuis Brussel (UZ Brussel) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
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This study uses a prospective, randomized, crossover design during which biological samples will be collected during each treatment session (3 in total over the course of 1 week).
During each session, the patient will be treated by another dialyzer membrane (polysulphone vs asymmetric triacetate vs polymethyl methacrylate)
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| Use of an asymmetric triacetate membrane | Device | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro) |
|
| Use of a polymethyl methacrylate membrane | Device | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray) |
|
| over the course of 1 week (3 hemodialysis sessions) |
| Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition | Biological evaluation of systemic coagulation activation and inflammation in relation to dialysate composition. Markers will be measured using multiplex-based immunoassays from plasma samples collected. | Over the course of 1 week (3 hemodialysis sessions) |
| Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition | Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition. | Over the course of 1 week (3 hemodialysis sessions) |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000090882 | Thromboinflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| 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 |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007249 | Inflammation |
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