H+ Mobilization With Dialysate Bicarbonate Variation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Lactate levels
研究概览
简要总结
The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath [HCO3-] of 35 mEq/L and an [acetate] of 4 mEq/L, and second, to determine whether reducing bath [HCO3-] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood [HCO3-]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath [HCO3-].
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Patients must be 18 years or older,
- •Have been on dialysis for at least 1 year,
- •Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
- •Be reasonably nourished (serum albumin > 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
- •Self-reported urine output of <200 cc/day
- •Functioning arteriovenous fistulas or grafts for dialysis access
- •Currently dialyzing at a dialysate [HCO3-] of 33-37 mEq/L.
排除标准
- •Acute illnesses of any kind,
- •Hospitalization in the prior 3 months (except for vascular access related),
- •Significant congestive heart failure, liver or lung failure.
- •Pre-dialysis blood [HCO3-] <19 mEq/L) (to reduce the risk of metabolic acidosis )
结局指标
主要结局
Lactate levels
时间窗: through study completion, a period of 3 weeks
7 tests conducted through the dialysis treatment after the long interdialytic interval
H+ mobilization
时间窗: through study completion, a period of 3 weeks
7 tests conducted through the dialysis treatment after the long interdialytic interval
次要结局
未报告次要终点