Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls
研究概览
简要总结
This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.
详细描述
Investigators will try to perform dialysis with a low bicarbonate bath which will leave patients blood pH (Hydrogen ion concentration) relatively unchanged then switch to a normal bicarbonate bath during the second half of dialysis so that they attain the pH (Hydrogen ion concentration) they normally would. Investigators will use these measurements to test test the hypothesis that Indoxyl Sulfate (IS) binds to proteins with greater affinity under basic conditions and further to test the hypothesis that it is possible to remove a greater amount of Indoxyl Sulfate (IS) when patients are maintained relatively acidotic during dialysis for a longer period of time due to the greater availability of free IS that can pass through the dialyzer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Stable Dialysis for at least 6 months
排除标准
- •Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L
- •Hospitalization within the past 12 months
- •Adults unable to consent
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Low bicarbonate dialysate First
Dialysis with low bicarbonate dialysate (expected normal for an adult ~24 mEq) for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half.
干预措施: Low bicarbonate dialysate First (Drug)
Low bicarbonate dialysate First
Dialysis with low bicarbonate dialysate (expected normal for an adult ~24 mEq) for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half.
干预措施: Normal bicarbonate dialysate (Drug)
Normal bicarbonate dialysate First
Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate
干预措施: Normal bicarbonate dialysate First (Drug)
Normal bicarbonate dialysate First
Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate
干预措施: Low bicarbonate dialysate (Drug)
结局指标
主要结局
Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls
时间窗: 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
次要结局
- Change in pH(1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes)