12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Region Skane
- 主要终点
- Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
研究概览
简要总结
The medium cut-off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.
The aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.
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
- •Ongoing HDF treatment (>3 months)
- •Albumin ≥ 30
- •No acute myocardial infarction within 3 months.
- •Swedish or english speaking.
排除标准
- •Not able to understand the study information.
研究组 & 干预措施
MCO-HD
Hemodialysis with Medium Cut-Off filter
干预措施: MCO-HD (Device)
MCO-HD
Hemodialysis with Medium Cut-Off filter
干预措施: high-flux HDF (Device)
High-flux HDF
Hemodiafiltration with standard high-flux filter
干预措施: MCO-HD (Device)
High-flux HDF
Hemodiafiltration with standard high-flux filter
干预措施: high-flux HDF (Device)
结局指标
主要结局
Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
时间窗: 12 weeks
Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
时间窗: 12 weeks
次要结局
- Comparison of mean nPCR after 12 weeks.(12 weeks)
- Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.(8 weeks)
- Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.(12 weeks)
- Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.(12 weeks)
- Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).(12 weeks)
- Comparison of number of adverse effects during the study period.(12 weeks)
- Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).(12 weeks)