Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07206524

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

Led by Universitair Ziekenhuis Brussel · Updated on 2025-11-17

15

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

Sponsors

U

Universitair Ziekenhuis Brussel

Lead Sponsor

U

University of Rochester

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants to the OMAGOD pilot trial
Not Eligible

You will not qualify if you...

  • Patients who are not participating in the OMAGOD pilot trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090

Actively Recruiting

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Research Team

F

Florine Janssens, Medical doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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