Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants to the OMAGOD pilot trial
排除标准
- •Patients who are not participating in the OMAGOD pilot trial
研究组 & 干预措施
Acetic acid dialysate (0.5 mmol/L Mg)
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.
干预措施: Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L (Other)
Citric acid dialysate (Mg 1.0 mmol/L)
Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citric acid dialysate containing magnesium 1.0 mmol/L
干预措施: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L (Other)
Citric acid dialysate (Mg 0.75 mmol/L)
Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citrate-enriched dialysate containing magnesium 0.75 mmol/L
干预措施: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L (Other)
结局指标
主要结局
Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
时间窗: 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)
Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
时间窗: 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)
次要结局
- 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 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 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))
- 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 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 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))
- 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))