Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- protein-bound toxin removal
研究概览
简要总结
A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.
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
- •Age ≥18 years
- •CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
- •Hematocrit >30 %
- •Routine anticoagulation and erythropoietin regimen
- •No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
- •No ongoing infection
- •Signed informed consent form
排除标准
- •Inclusion criteria not met
- •Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
- •Unstable clinical condition (e.g. cardiac or vascular instability)
- •Life expectancy less than 12 months
- •Known coagulation problems
- •Patients participating in another study interfering with the planned study
结局指标
主要结局
protein-bound toxin removal
时间窗: pre and post dialysis treatment
low-molecular weight protein removal
时间窗: pre and post dialysis treatment
small solute removal
时间窗: pre and post dialysis treatment
次要结局
未报告次要终点
