NCT00724633已完成3 期
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Ambulatory blood pressure
研究概览
简要总结
Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 on 3 times weekly hemodialysis of at least 3 months
- •elevated average ambulatory blood pressures
- •current dialysate sodium prescription 140mEq/L
- •average pre-dialysis serum sodium <140mEq/L
排除标准
- •frequent intradialytic hypotension
- •estimated life expectancy <1 year
- •non-adherence to dialysis prescription
- •pregnancy
- •inability or unwillingness to complete study measures
研究组 & 干预措施
1
Other
standard dialysate Na 140 mEq/L
干预措施: Lowering the dialysate sodium (Other)
2
Active Comparator
dialysate sodium equal to patient's predialysis serum Na
干预措施: Lowering the dialysate sodium (Other)
3
Active Comparator
dialysate sodium lower than patient's predialysis plasma sodium
干预措施: Lowering the dialysate sodium (Other)
结局指标
主要结局
Ambulatory blood pressure
时间窗: 3 months
Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study
次要结局
- intradialytic hypotension rate, intradialytic symptoms(3 months)
- QOL Scores (KDQOL, mins to recovery)(3 months)
- thirst(3 months)
- mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance(3 months)
研究者
研究点 (2)
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