Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in inflammation
研究概览
简要总结
This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.
详细描述
Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.
Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.
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
盲法说明
no masking
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
- •time since initiation of dialysis > 3 months
- •age > 18 years
排除标准
- •time since initiation of dialysis < 3 months
- •age < 18 years
- •ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
- •major surgery less than 2 weeks before inclusion in the study
- •pregnancy
- •mental illness
- •lack of written and informed consent
研究组 & 干预措施
Standard High Flux Dialysis
Standard High Flux Dialyzer
干预措施: Standard High Flux Dialyzer (Device)
MCO Dialysis
Theranova Dialyzer
干预措施: Medium cut off dialysis (Device)
结局指标
主要结局
Change in inflammation
时间窗: 240 days (cross-over design, multiple measurements)
change of inflammatory score (inflammatory score is derived from multiple biomarkers)
次要结局
- change in calcification propensity(240 days (cross-over design, multiple measurements))
- Change in calcification status(240 days (cross-over design, multiple measurements))