Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
研究概览
简要总结
Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable on hemodialysis >= 6 months
- •of which presently on high-flux HD >= 1 month
- •18 years < age < 85 years
- •blood flow rate >= 300ml/min
排除标准
- •expected survival < 1 year
- •expected transplant within < 1 year
- •infectious diseases
- •pregnancy
- •chronic inflammation condition
- •treated with single needle dialysis
- •presently treated with hemodiafiltration or low-flux hemodiafiltration
- •expected intradialytic body weight gain >= 4kg
结局指标
主要结局
To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
时间窗: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?
时间窗: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
次要结局
未报告次要终点