Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in serum CRP (C-reactive protein)
研究概览
简要总结
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •creatinine clearance <5ml/min
- •treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
- •treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy
排除标准
- •known neoplastic disease
- •active chronic inflammatory disease
- •active acute inflammatory disease
研究组 & 干预措施
Single arm
干预措施: Dialysis Solutions (Drug)
结局指标
主要结局
Change in serum CRP (C-reactive protein)
时间窗: Months 4th to 6th
Change in serum CRP during the 3 months of citrate-buffered dialysis
次要结局
- Change in dialysis efficiency(Every 3 months (month 0, 6, 3 and completion - 9))
- Change in serum CRP (C-reactive protein)(Every 3 months (month 0, 6, 3 and completion - 9))
研究者
Vincenzo Cantaluppi
Associate professor of Nephrology
A.O.U. Città della Salute e della Scienza