Effects of Convective Therapies in Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 32
- 主要终点
- Intradialytic symptomatic hypotension
研究概览
简要总结
Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.
To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis patients aged 18-80 years
- •thrice-weekly HD or HDF for at least 6 months
- •body weight less or equal to 90 Kg
- •stable clinical condition
- •written consent
排除标准
- •infections
- •malignancies
- •active systemic diseases
- •active hepatitis or cirrhosis
- •unstable diabetes
- •diuresis higher than 200 ml/24h
- •dysfunction of vascular access
- •blood flow rate less than 300 ml/min
研究组 & 干预措施
low-flux hemodialysis
online pre-dilution hemofiltration
干预措施: online pre-dilution hemofiltration (Procedure)
online pre-dilution hemodiafiltration
干预措施: online pre-dilution hemodiafiltration (Procedure)
结局指标
主要结局
Intradialytic symptomatic hypotension
时间窗: all dialysis sessions, three per week, for 2 years
Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention
次要结局
- Resistance to erythropoiesis-stimulating agents(Monthly for 2 years)
- Calcium-phosphate metabolism(Monthly for 2 years)
- Beta2 microglobulin(Every six months for 2 years)
研究者
Prof. Francesco Locatelli
Professor Francesco Locatelli
A. Manzoni Hospital