Application of Citrate Dialysate in Chronic Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- Occurrence of clinically relevant acid-base disturbances
研究概览
简要总结
Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.
详细描述
It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •signed informed consent
- •patients of either sex aged ≥ 18 years
- •stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
- •patients without planned or predictable changes within diet, anticoagulation and medication regimen
排除标准
- •pregnancy or lactation or woman in child bearing age without effective contraception
- •planned surgeries or hospital stay within the next 9 weeks
- •use of catheter as vascular access for dialysis
- •severe comorbidities not allowing to follow the study protocol
- •concomitant participation in another study
- •previous participation in this study
结局指标
主要结局
Occurrence of clinically relevant acid-base disturbances
时间窗: patients are followed for 8 weeks
during or post-dialysis severe alkalosis with pH ≥ 7.55
Occurrence of clinically relevant calcium disturbances
时间窗: patients are followed for 8 weeks
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
次要结局
- Occurrence of clinically relevant adverse events(patients are followed for 8 weeks)
- Occurrence of clinically relevant acid-base disturbances(patients are followed for 8 weeks)
- Occurrence of clinically relevant intradialytic complications (adverse events)(patients are followed for 8 weeks)