A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Adequacy of Chronic Dialysis
研究概览
简要总结
Study Goal is to determine the impact of dialysate flow rate (Qd) on Subject reported dialysis related symptoms and on time to recovery post dialysis.
详细描述
The objective of this study is to determine if Subjects who report dialysis symptoms while meeting adequacy (as determined by Kt/V of 1.2 or greater) on thrice weekly dialysis or who have a recovery time of at least 4 hours when treated on a conventional, i.e. non Tablo, hemodialysis device feel better with a reduced dialysate flow rate of 300ml/min based on an assessment of time to recovery post dialysis and Subject reported symptoms via a modified weekly ESAS survey.
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)
盲法说明
Only Subjects will be blinded to the dialysis device Qd.
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 has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- •Subject is at least 18 of age.
- •Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis.
- •Subject is currently stable on dialysis for at least 3 months on a conventional dialysis machine and Qd of 500ml/min or higher with no change in the following dialysis prescription parameters over that time: Qb, Qd, Dialyzer, Time.
- •Subject has a baseline Kt/V of greater than 1.
- •Subject has a stable vascular access.
- •Subject reports time to recovery of more than 4 hours or a modified ESAS with at least 5 symptoms of which at least 2 are rated as moderate (rating of 4-6) or severe (rating of 7-10).
排除标准
- •Subject is unable to complete the questionnaires.
- •Subject is pregnant or planning to become pregnant.
- •Subject is scheduled for a change in modality or expected kidney transplant in the next 3 months.
- •Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.
结局指标
主要结局
Adequacy of Chronic Dialysis
时间窗: 4 weeks
Adequacy (as determined by Kt/V of 1.2 or greater) of patients treated with chronic (3x/wk), dialysis or who have a recovery time of more than 4 hours, when treated on a Tablo hemodialysis device versus conventional, i.e. non Tablo, hemodialysis device.
Post-Treatment Symptomology
时间窗: 0-24 Hours
Occurrence Rate of post-treatment symptoms (24hrs) when treated with a reduced dialysate flow rate of 300ml/min, based on an assessment of time to recovery post dialysis when using Tablo hemodialysis device, when compared to occurrence of post-treatment symptoms (24hrs) reported with dialysate flow rates ≥ 500 ml/min on conventional dialysis machines.
次要结局
- Weekly Modified Edmonton Symptom Assessment System (ESAS)(4 weeks)