Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 2
- 主要终点
- tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions
研究概览
简要总结
The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.
详细描述
The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate:
- Quality of life evaluated with the KDQOL questionnaire
- Incidence of cardiovascular events
- Influence of the technic on cardiovascular, inflammatory and infectious risk factors
- Mortality
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who has signed the written consent form
- •Patient aged > 65 and < 90 years
- •With creatinine clearance < 10 mL/min
- •On dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions
- •Erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dL without any variation of more than 2g/dL for less than 3 months)
- •Without any problem of vascular access
排除标准
- •Patient aged < 65 and > 90 years
- •Presence of severe malnutrition (albumin < 20 g/L)
- •Unstable clinical condition
- •Unipuncture or failed vascular access flow
- •Known problems of coagulation
研究组 & 干预措施
On line Hemodiafiltration
Hemodialysis patients treated with on line hemodiafiltration technic
干预措施: On line Hemodiafiltration (Procedure)
hemodialysis
Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers
干预措施: Hemodialysis (Procedure)
结局指标
主要结局
tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions
时间窗: between day 30 and day 120 of treatment
次要结局
- Quality of life evaluated with the KDQOL questionnaire(day 0, 180, 365, 730)
- Incidence of cardiovascular events(day 180, 365, 730)
- Influence of the technic on mineral metabolism disturbances(day 180, 365, 730)
- All cause and cardiovascular mortality(day 180, 365, 730)
- Influence of the technic on inflammatory parameters(day 180, 365, 730)
- Influence of the technic on microbiological safety(day 180, 365, 730)
- Influence of the technic on oxidative stress parameters(day 180, 365, 730)