Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Reduction ratio (RR) of middle molecules (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 major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.
Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •No Acute Myocardial Infarction within 3 months.
排除标准
- •Not able to understand the study information.
研究组 & 干预措施
First MCO-HD, then High-flux-HDF
Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF
干预措施: MCO-HD (Device)
First MCO-HD, then High-flux-HDF
Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF
干预措施: High-flux HDF (Device)
First High-flux-HDF, then MCO-HD
Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD
干预措施: MCO-HD (Device)
First High-flux-HDF, then MCO-HD
Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD
干预措施: High-flux HDF (Device)
结局指标
主要结局
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
时间窗: 4 hours
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
时间窗: 240 minutes
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
时间窗: 30 minutes
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
时间窗: 60 minutes
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
时间窗: 120 minutes
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
次要结局
- Number of Adverse Events(4 hours)
- RR of large molecules (Albumin, Transferrin, IgG)(4 hours)
- RR of small molecules (Urea, Phosphate, Creatinine)(4 hours)
- Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)(240 minutes)
- Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)(240 minutes)
- Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)(30 minutes)
- Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)(60 minutes)
- Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)(120 minutes)
- Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)(30 minutes)
- Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)(60 minutes)
- Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)(120 minutes)