Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Rochester | OTHER |
| Vrije Universiteit Brussel | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetic acid dialysate (0.5 mmol/L Mg) | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) during which patients will be dialyzed with standard acetate-based dialysate containing 0,5 mmol/L magnesium. |
|
| Citric acid dialysate (Mg 1.0 mmol/L) | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citric acid dialysate containing magnesium 1.0 mmol/L |
|
| Citric acid dialysate (Mg 0.75 mmol/L) | Active Comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citrate-enriched dialysate containing magnesium 0.75 mmol/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L | Other | Change dialysate compositions being used during hemodialysis treatment in each arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition | 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) | Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21) |
| Measure | Description | Time Frame |
|---|---|---|
| differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition | differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition, evaluated by hematologic cell analyzer | Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florine Janssens, Medical doctor | Contact | +324749435 | florine.janssens@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| 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) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
| Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L | Other | Standard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions. |
|
| Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L | Other | Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions. |
|
| 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 | 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. | 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 | 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. | 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 | Quantification of NET biomarkers in blood and rinse fluids 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) |
| ID | Term |
|---|---|
| D000090882 | Thromboinflammation |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
Not provided
Not provided