In Vivo Evaluation of the Nipro Elisio™ Dialyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- pre-dialytic serum beta-2 microglobulin level
研究概览
简要总结
The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
详细描述
Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •CKD dialysis patients on treatment with three times a week HD for more than three months
- •with a stable anticoagulation scheme
- •with haemoglobin level >10.5 g/dL
- •with vascular access allowing a stable blood flow of 300 mL/min during treatment
排除标准
- •patient already enrolled in another study
- •pregnancy
- •symptoms or signs of acute/chronic inflammatory or infectious diseases
结局指标
主要结局
pre-dialytic serum beta-2 microglobulin level
时间窗: Month 1 (after one month)
次要结局
- reduction rate of low molecular weight solutes (urea and creatinine)(Month 0, 1, 2, 3, 4)
- dialysis dose (urea KT/V)(Month 0, 1, 2, 3, 4)
- instantaneous clearance of low molecular weight solutes (urea and creatinine)(Month 0, 1, 2, 3, 4)
- inflammatory markers (CRP, fibrinogen, orosomucoide)(month 0, 1, 2, 3, 4)
- inflammatory marker (interkeukin 6)(month 0, 4)
- nutritional status (albumin, transthyretin, homocysteine)(Month 0, 1, 2, 3, 4)
- endothelial progenitor cells(Month 0, 1, 2, 3, 4)
- inflammatory mononuclear cell activation(Month 0, 1, 2, 3, 4)
- kappa and lambda light chains(Month 0, 4)
- oxidative stress parameters (superoxide anion, AOPPs, AGEs)(Month 0, 4)
- coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)(Month 0, 4)
- apoptosis markers (soluble FAS and FAS ligand)(Month 0, 4)
- bone markers (bone PAL, Cross Laps, TRAP5b)(Month 0, 4)