Safety and Efficacy of Hemodiafiltration With On-Line Preparation of Substitution Fluid Using the Gambro AK 200 ULTRA System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Primary Goal: To assess the safety and efficacy of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA for the treatment of chronic renal failure.
研究概览
简要总结
This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.
详细描述
The AK200 ULTRA is a new device in the United States, but has been used for several years in Europe. The AK200 ULTRA is a single unit which is preprogrammed to provide standard hemodialysis as well as hemofiltration and hemodiafiltration with on-line preparation of the substitution fluid The AK200 ULTRA hemofiltration and hemodiafiltration is performed using a high flux membrane with high ultrafiltration rates compensated by volumetrically controlled infusion of on-line prepared substitution fluid. The AK200 ULTRA is, therefore, capable of providing dialysis treatments which can improve the removal of medium to high weight molecules without the difficulties associated with the manual measurement and administration of external substitution fluid.
This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis. This study is motivated by the need for a commercially available product capable of administering hemofiltration and hemodiafiltration in a clinical setting. The ultimate goal of this study is to improve morbidity and mortality in the ESRD patient population in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 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
- •Subject received chronic dialysis therapy
- •Subject was stable on three dialysis sessions per week
- •Subject was able to understand and sign the informed consent
排除标准
- •) On chronic renal replacement therapy for less than three (3) months 2) Hospitalization for reasons other than vascular access complications in the past three (3) months 3) HIV + 4) Hepatitis B+ 5) Pregnancy, verified by pregnancy test for women of child bearing potential 6) Access recirculation > 10% 7) Hematocrit less than 26% 8) History of non compliance 9) Pediatric patients, defined as less than 18 years old
结局指标
主要结局
Primary Goal: To assess the safety and efficacy of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA for the treatment of chronic renal failure.
时间窗: 6 months
次要结局
未报告次要终点