End Stage Renal Disease (ESRD), Hemodialysis, Hemodialysis Complication, Thromboinflammation
Conditions
Keywords
hemodialysis, thromboinflammation, neutrophil extracellular trap formation, dialysate composition, cellular activation, transcriptome analysis
Brief summary
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
OTHERHemodialysis 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.
OTHERHemodialysis 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.
OTHERHemodialysis 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.
Sponsors
University of Rochester
Vrije Universiteit Brussel, Jette, Belgium
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
This study focuses on the additional collection of biological samples during the pilot OMAGOD trial. The original study design-a prospective, randomized, single-blind, parallel-group crossover study-will remain unchanged other than the collection of additional samples. Sample collection for this study will be conducted exclusively at our center and will take place during the last hemodialysis session of each treatment period (3 HD sessions per participant).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants to the OMAGOD pilot trial
Exclusion criteria
* Patients who are not participating in the OMAGOD pilot trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition | 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 |
| 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 | 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. |
| Differences in coagulation activation and inflammatory biomarkers measured by multiplex-based immunoassays in relation to dialysate composition | 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. |
| Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition | 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. |
Countries
Belgium
Contacts
Primary ContactFlorine Janssens, Medical doctor
Outcome results
None listed