Permeability Enhancement to Reduce Chronic Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- change of CD162 expression on monocytes
研究概览
简要总结
Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis treatment for ≥ 3 months
- •Dialysis 3x weekly
- •Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
- •Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
- •CRP > 5mg/L at least once within 12 weeks before inclusion
- •Age > 18 and < 99 Years
- •Ability to give written informed consent
排除标准
- •Missing informed consent form
- •Clinically manifested infection or current CRP-value > 50mg/L
- •Serum albumin < 35g/L
- •Intake of immune suppressive medication
- •Pregnancy or lactation
- •Participation in a different study
结局指标
主要结局
change of CD162 expression on monocytes
时间窗: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)
次要结局
- Albumin blood level(8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase))