Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L, Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L.
- Who it may be relevant to
- Registry conditions: Hemodialysis, Thromboinflammation, Hemodialysis Complication, End Stage Renal Disease (ESRD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
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.
Interventions
- Other Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L
Change dialysate compositions being used during hemodialysis treatment in each arm. - Other Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L
Standard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions. - Other Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L
Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.
Primary outcome measures
- Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition [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)]
Secondary outcome measures (4)
- differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition [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 and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition [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 coagulation activation and inflammatory biomarkers measured by multiplex-based immunoassays in relation to dialysate composition [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 Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition [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)]
Eligibility criteria
Inclusion criteria
- Participants to the OMAGOD pilot trial
Exclusion criteria
- Patients who are not participating in the OMAGOD pilot trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- Universitair Ziekenhuis Brussel — Brussels
Identifiers
NCT: NCT07206524 · 25113_PILOTOMAGOD