NCT00694031已完成4 期
A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 906
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Currently undergoing hemodialysis
- •Clinical stability
- •Stable vascular access
排除标准
- •Chronic inflammatory diseases
- •Liver cirrhosis
- •Malignancies
- •Chronic immunosuppressant or antiinflammatory use
- •Dialysis through temporary catheter or single puncture
研究组 & 干预措施
A
Active Comparator
Hemodialysis
干预措施: Hemodialysis (Procedure)
B
Experimental
On-line hemodiafiltration
干预措施: On-line hemodiafiltration (Procedure)
结局指标
主要结局
Survival
时间窗: 36 months
次要结局
未报告次要终点
研究者
Francisco Maduell
Dr
Hospital Clinic of Barcelona
研究点 (4)
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