End Stage Renal Disease (ESRD), Hemodialysis, Hemodialysis Treatment, Thromboinflammation
Conditions
Keywords
hemodialysis, thromboinflammation, dialyzer membrane, neutrophil extracellular traps, thrombin generation
Brief summary
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: * Assess whether the dialyzer membrane influences leukocyte and platelet activation . * Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation. * Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.
Interventions
DEVICEUse of a polysulfone membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)
DEVICEUse of an asymmetric triacetate membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)
DEVICEUse of a polymethyl methacrylate membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)
Sponsors
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
NIER research group
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dialysis vintage ≥ 3 months * Treatment schedule of 3x4 hours weekly * well functioning dual lumen vascular access * Treatment with ASA 80-100mg daily * Patients able and agree to provide signed informed consent
Exclusion criteria
* Known vascular access dysfunction defined by FOR CATHETER ACCESS: high dose urokinase use within 4 weeks prior to study participation, planned catheter opacification, Qb \<250mL/min within the 2 weeks prior to study participation FOR AV ACCESS: planned AV access intervention, recent AV access intervention within 4 weeks prior to study participation, known AV access dysfunction * Known active malignancy and/or active autoimmune disease * Known clotting/bleeding disorders * Current treatment with immunosuppressive medication * Current treatment with P2Y12 receptor antagonists (including clopidogrel, prasugrel, ticlodipine, cangrelor, ticagrelor), epoprostenol and glycoproteine IIb/IIIa receptor antagonists (tirofiban) * Current treatment with oral anticoagulation maintenance therapy, including vitamin K antagonists or direct oral anticoagulants * Current treatment with low molecular weight heparins (LMWH), heparinoids, bivalirudin, fondaparinux, protein C, or antithrombin. * Active infection and/or ongoing systemic antimicrobial treatment. * Hospitalized patients * Patients treated with heparin-free hemodialysis * Recent (\<1 week) platelet transfusion or packed cells transfusion * Patients receiving intradialytic TPN * Patients requiring intravenous iron administration during dialysis (EPO or Parsabiv administration will be postponed until after disconnection from the dialysis circuit and after T240 blood sampling). * Patients with cytopenia affecting either white blood cells (WBC \< 4x10³/mm³) or platelets defined as (platelet counts \<100x10³/mm³) * Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition | Over the course of 1 week (3 hemodialysis sessions) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | over the course of 1 week (3 hemodialysis sessions) | 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. |
| Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition | Over the course of 1 week (3 hemodialysis sessions) | 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. |
| Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition | Over the course of 1 week (3 hemodialysis sessions) | Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORFlorine Janssens, Medical Doctor
Universitair Ziekenhuis Brussel (UZ Brussel)
Outcome results
None listed