Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial

What this Trial Is About

Researchers are investigating how different compositions of dialysate used during hemodialysis affect thromboinflammation, which is the activation of immune cells and clotting processes during treatment. This study focuses on how varying magnesium levels and acid types in the dialysate influence immune responses in patients undergoing hemodialysis. The research is part of the monocentric plus phase of the multicentric pilot OMAGOD trial. Participants will receive standard hemodialysis treatments three times a week, each lasting four hours. They will experience three different dialysate types in a randomized crossover design, each used for two weeks (six sessions): standard acetate-based dialysate with 0.5 mmol/L magnesium, citric acid dialysate with 1.0 mmol/L magnesium, and citrate-enriched dialysate with 0.75 mmol/L magnesium. During certain sessions in the last week of each treatment phase, blood samples will be taken at various times, and the used dialysis circuits will be rinsed to collect cells. Throughout the study, researchers will monitor immune cell and platelet activation by analyzing blood and rinse fluid samples using various laboratory techniques including flow cytometry and immunoassays. They will also measure neutrophil extracellular trap (NET) formation and identify new biomarkers related to thromboinflammation. The primary outcome is the difference in leukocyte counts in the rinse fluids across dialysate types during selected dialysis sessions, with multiple secondary outcomes related to platelet counts, activation markers, and coagulation biomarkers. The study will continue until December 2026.

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