Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
研究概览
简要总结
The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by measuring blood levels of urea at the beginning and end of dialysis at two different dialysate flow rates.
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
- 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
- •Adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (ESRD) three times a week for at least three months with a stable treatment prescription
- •Subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
- •Subject with an AV fistula or graft capable of routinely delivering a blood flow rate of 400 mL/min
排除标准
- •Subject who is non-compliant with dialysis prescription
- •Subject whose hemodialysis schedule is not three times a week
- •Subject using a catheter for blood access
- •Subject who is not anticoagulated with heparin during hemodialysis
- •Subject with a current malignancy involving sites other than skin
- •Subject with a history of drug or alcohol abuse within the last six months
- •Subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
- •Subject who is pregnant
- •Subject who is considered incompetent to give an informed consent
- •Subject with a positive test for hepatitis B surface antigen within the past 30 days (testing for hepatitis B surface antigen is not required for subjects who have tested positive for hepatitis B antibody within the past year and any such patients will not be subject to this exclusion criterion)
- •Subject with known HIV infection (if this is not known, no HIV testing will be performed
结局指标
主要结局
Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
时间窗: 4 weeks
The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the "single-pool" Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).
次要结局
- Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.(4 weeks)
- Kt/V Determined From Measurements of Ionic Dialysance(4 weeks)