Modulation of Vascular Calcification in Chronic Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
研究概览
简要总结
50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment.
Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.
Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.
Primary endpoint:
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.
Secondary Endpoints:
Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months
Cell culture: Incubation of VSMC with serum samples obtained after 6 months
- Alizarin staining/WST-8
- Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants
- Apoptosis
The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years an older
- •Chronic dialysis patients for at least 3 months
排除标准
- •Serum albumin <32g/L at the last routine albumin measurement
- •Pregnancy
结局指标
主要结局
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
时间窗: Six months
Serum samples will be drawn at the beginning of the trial and after six months treatment with either High-Flux or Medium Cut-Off filters. Vascular smooth muscle cells will be incubated with thee serum samples and calcification will be assessed with Alkaline Phosphatase/ WST8
次要结局
- Aortic Pulse wave velocity(Six months)
- Calcification propensity(Six months)
- Physical activity level(Six months)
- Cell culture: Incubation of VSMC with serum samples and assessment of • Alizarin staining/WST-8 • Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants • Apoptosis(Six months)
研究者
Daniel Zickler
MD
Charite University, Berlin, Germany