NCT02795286已完成不适用
Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Plasma Sodium
研究概览
简要总结
The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.
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
- Single (Participant)
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 must be in clinically stable condition as judged by the treating physician, and demonstrated by stable medical history, physical examination, and laboratory testing for 30 days prior to enrollment.
- •Subject must be receiving HD or hemodiafiltration (HDF) for at least 30 days prior to study enrollment, be dialyzing a minimum of 3 times per week in an in-center setting and each treatment session must be between 3.5 and 5 hours in duration.
- •Subject has a stable functioning vascular access (arteriovenous [AV] fistula, graft, or dual-lumen tunneled catheter) based on the judgment of the treating physician and is performing dual-needle therapy with an actual blood flow rate of 250 - 400 mL/min.
- •Subject has a pre-dialysis plasma sodium of ≥132 mmol/L for at least 60 days prior to study enrollment.
- •Subject has achieved a dialysis dose of stdKt/Vurea ≥ 2.1 within 60 days prior to enrollment.
- •Subject has a pre-dialysis hemoglobin ≥ 90 g/L measured at Screening.
排除标准
- •Female subjects who are pregnant, lactating, or planning to become pregnant during the study period.
- •Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide Informed Consent and/or comply with protocol procedures.
- •Subjects with a medical condition that the investigator thinks may interfere with the study objectives.
- •Subjects with significant signs of access recirculation as judged by the treating physician.
结局指标
主要结局
Change in Plasma Sodium
时间窗: Up to 9 weeks
Evaluation of Blood Pressure
时间窗: Up to 9 weeks
Change in MCV (Erythrocyte Mean Corpuscular Volume)
时间窗: Up to 9 weeks
Occurrence of Hypotensive Episodes
时间窗: Up to 9 weeks
Change in Plasma Tonicity
时间窗: Up to 9 weeks
Evaluation of Heart Rate
时间窗: Up to 9 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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