Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hemotech
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Evaluation of middle molecules extraction
研究概览
简要总结
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.
To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.
详细描述
Medical devices studied :
- Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany
- Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany
- VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan
- Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia
These hemodialyzers are EC marked and are used in their own indications.
Schema
Details of the cross-over plan :
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
- •Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
- •Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
- •Patient treated before with high permeability membrane
- •Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
- •Patient treated with a high surface area dialyzer ≥ 1,8 m²
- •Patient covered by the social French health organism
- •Patient informed of the study goals and having signed the informed consent
排除标准
- •Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
- •Patient with a fast progressive chronic disease
- •Patient with an uncontrolled anemia
- •Patient refusing to sign the informed consent
- •Pregnant or nursing patient
- •Pediatric patient
- •Patient under tutorship
研究组 & 干预措施
Hemodialysis
patients treated by conventionnal hemodialysis
干预措施: VIE A Hemodialyzer (Device)
Hemodialysis
patients treated by conventionnal hemodialysis
干预措施: Rexsys 27H hemodialyzer (Device)
Hemodialysis
patients treated by conventionnal hemodialysis
干预措施: Leoceed 21HX hemodialyzer (Device)
Hemodialysis
patients treated by conventionnal hemodialysis
干预措施: Polypure 22S+ hemodialyzer (Device)
Hemodiafiltration post dilution
patients treated by HDF post-dilution
干预措施: VIE A Hemodialyzer (Device)
Hemodiafiltration post dilution
patients treated by HDF post-dilution
干预措施: Rexsys 27H hemodialyzer (Device)
Hemodiafiltration post dilution
patients treated by HDF post-dilution
干预措施: Leoceed 21HX hemodialyzer (Device)
Hemodiafiltration post dilution
patients treated by HDF post-dilution
干预措施: Polypure 22S+ hemodialyzer (Device)
结局指标
主要结局
Evaluation of middle molecules extraction
时间窗: one week per dialyzer per patient
Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)
次要结局
- Monitoring of Nutrition status(one week per dialyzer per patient)
- Dialysis adequacy evaluation(one week per dialyzer per patient)
- Session tolerance(one week per dialyzer per patient)
- Extraction of uremic toxins(one week per dialyzer per patient)
- Handling of the devices(one week per dialyzer per patient)
- Biocompatibility assessment(one week per dialyzer per patient)
- Parameters inflammation(one week per dialyzer per patient)