Randomised, Cross Over Pilot Study Comparing Removal of beta2-Microglobulin by Standard Haemodialysis to Haemodialysis With a Novel Dialysis Membrane (P2SH) in Chronic Dialysis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
研究概览
简要总结
The purpose of this study is to determine whether a novel haemodialysis membrane, compared with the standard dialysis membrane, will increase the removal of beta2-microglobulin in chronic dialysis patients.
详细描述
Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. A new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Chronic haemodialysis patients for more than 2 years
- •Urine output <100 mL per day
- •3 haemodialysis sessions per week
- •Permanent arteriovenous dialysis access
排除标准
- •Serum albumin <25 g/L
研究组 & 干预措施
A
New larger pore membrane
干预措施: Larger pore haemodialysis membrane (Other)
A
New larger pore membrane
干预措施: Standard haemodialysis membrane (Other)
B
Standard haemodialysis membrane
干预措施: Larger pore haemodialysis membrane (Other)
B
Standard haemodialysis membrane
干预措施: Standard haemodialysis membrane (Other)
结局指标
主要结局
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
时间窗: 5 weeks (2 weeks in each arm, 1-week washout period)
次要结局
- Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane(5 weeks (2 weeks in each arm, 1-week washout period))
- Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane(5 weeks (2 weeks in each arm; 1-week washout period))