This clinical trial investigates whether the composition of dialysate influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of magnesium concentration and acid type in dialysate on immune cell activation and thromboinflammatory responses.
Patients participating to the multicentric pilot OMAGOD trial will be invited to participate to this monocentric plus study.
In the pilot OMAGOD trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialysate compositions in a crossover design. Each treatment phase lasts two weeks (six sessions).
For the local plus study, during selected sessions (3 per patient - midweek hemodialysis session of the last week of a treatment period), 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 dialysate composition influences leukocyte and platelet activation . * Evaluate whether the dialysate composition influences neutrophil extracellular trap (NET) formation. * Identify novel biomarkers of thromboinflammation using transcriptomic analysis of immune cells.
Participants to the OMAGOD pilot trial
Patients who are not participating in the OMAGOD pilot trial
Crossover
Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L
Other interventionChange dialysate compositions being used during hemodialysis treatment in each arm.
Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L
Other interventionStandard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions.
Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L
Other interventionDialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.
Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
The primary endpoint will be the difference in leukocyte counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition (acetic acid vs. citric acid Mg 0.75 mmol/L vs. citric acid 1.0 mmol/L)
differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition
differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition, evaluated by hematologic cell analyzer
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.
Differences in coagulation activation and inflammatory biomarkers measured by multiplex-based immunoassays in relation to dialysate composition
Biological evaluation of systemic coagulation activation and inflammation in relation to dialysate composition. Biomarkers will be measured using multiplex-based immunoassays from plasma samples collected during midweek dialysis 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.
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Universitair Ziekenhuis Brussel
Lead sponsor
University of Rochester
Collaborator
Vrije Universiteit Brussel
Collaborator
