Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation

N/ARecruitingNCT07206524

Universitair Ziekenhuis Brussel15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Hemodialysis Thromboinflammation

Interventions

Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/LOTHER

Change dialysate compositions being used during hemodialysis treatment in each arm.

Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/LOTHER

Standard 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/LOTHER

Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.

Outcomes

Primary Outcomes

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)