NCT Number: NCT07206524
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brussels, 1090, Belgium
Location status: Recruiting
Florine Janssens, Medical doctor
CONTACT
Florine Janssens, Medical doctor
PRINCIPAL_INVESTIGATOR
Karlien François, Medical doctor, PhD
SUB_INVESTIGATOR
Nathalie Marmitte, Study coordinator
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Change dialysate compositions being used during hemodialysis treatment in each arm.
Standard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions.
Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.
Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
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)
Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition, evaluated by hematologic cell analyzer
Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
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.
Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
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.
Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.
Contact information is provided by the study sponsor or research team.
Universitair Ziekenhuis Brussel
Other
Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
Acronym: pilot OMAGOD +
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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