Changing magnesium and acid type in dialysis fluid to reduce clotting and immune activation
Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
This project tests whether changing the magnesium level and acid type in dialysis fluid can reduce immune-driven clotting and inflammation in people on maintenance hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07206524 on ClinicalTrials.gov |
What this trial studies
This nested monocentric sub-study enrolls participants from the multicenter OMAGOD pilot and uses a crossover design with three dialysate compositions given in two-week periods. Each participant receives standard hemodialysis while switching between citrate-acid and acetic-acid dialysates with different magnesium concentrations. During selected midweek sessions, serial blood samples are taken at baseline, hourly, and at the end of dialysis, and the used dialysis circuit is rinsed to collect adherent cells. Outcomes focus on immune cell activation, neutrophil extracellular trap formation, and other thromboinflammatory markers.
Who should consider this trial
Good fit: Ideal candidates are adults enrolled in the OMAGOD pilot who receive maintenance hemodialysis and can attend the Universitair Ziekenhuis Brussel for the extra sampling sessions.
Not a fit: Patients who are not enrolled in the OMAGOD pilot, those on non-hemodialysis modalities, or those unable to attend the additional sampling visits are not eligible and unlikely to benefit from this nested study.
Why it matters
Potential benefit: If successful, this approach could reduce dialysis-associated clotting and inflammation and improve treatment comfort and safety.
How similar studies have performed: Previous studies have reported reductions in clotting and inflammation with citrate-based dialysate and altered magnesium, but applying these specific magnesium concentrations with NET-focused measurements is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants to the OMAGOD pilot trial Exclusion Criteria: * Patients who are not participating in the OMAGOD pilot trial
Where this trial is running
Brussels
- Universitair Ziekenhuis Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Florine Janssens, Medical doctor — (1)Department of Nephrology and Arterial Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium. (2) Kidney diseases, dialysis & transplantation Research Unit (NIER), Vitality Research Group, Vrije Universiteit Brussel (VUB)
- Study coordinator: Florine Janssens, Medical doctor
- Email: florine.janssens@uzbrussel.be
- Phone: +324749435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.