A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Removal of Beta-2-microglobulin
研究概览
简要总结
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
详细描述
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
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
- •18 years of age or above
- •End stage kidney failure receiving hemodialysis for at least 3 years
- •Currently receiving hemodialysis at our center regularly
- •Written informed consent
排除标准
- •Patients with hemodiafiltration
- •Catheter-related blood stream infection in the preceding 4 weeks
- •Malfunctioning of HD catheter
- •Planned transfer to peritoneal dialysis or transplant within 90 days
- •History of active alcohol or substance abuse in the previous 6 months
- •Concurrent participation in another interventional study
- •Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
研究组 & 干预措施
MCO Dialyser
12 treatments (4 weeks) with Medium Cut-Off Dialyzer
干预措施: Theranova 400 (Device)
High Flux Dialyser
12 treatments (4 weeks) with High Flux Dialyzer
干预措施: Elisio-19H (Device)
结局指标
主要结局
Removal of Beta-2-microglobulin
时间窗: 4 weeks
Changes to Beta-2-microglobulin level
Changes to Quality of Life
时间窗: 27 weeks
Changes to Quality of life Using SF-36
次要结局
- Inflammatory state after intervention(4 weeks)
- Changes to Quality of Life(27 weeks)