Mechanisms and Treatment of Intradialytic Hypertension - Sodium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.
详细描述
Specific Aim #1 To determine in a crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate Na of 140), dialysis without ultrafiltration (dialysate Na of 140), or ultrafiltration alone (no dialysate) is associated with the an increase in systolic blood pressure during hemodialysis
Specific Aim #2 To determine in a crossover study of 15 maintenance hemodialysis with intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or nitric oxide during hemodialysis
SUBSTUDY AIMS
Specific Aim #1 To determine in a randomized 3-week, 2 period crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether high vs low dialysate-to-serum Na gradients impairs release of NO, increases ET-1 or causes an acute intradialytic increase in systolic BP,.
Specific Aim #2 TO determine in a randomized 16-week, 2-period crossover study of 30 hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high dialysate-to-plasma Na gradients to 8-weeks of low Na gradients on EC function (FMD and ADMA) and 44 hour ambulatory BP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on hemodialysis > 30 days
- •male and female participants, aged 18 to 85 years old, of all races and ethnic origin
- •ability to provide informed consent
- •Primary nephrologist deems patient is at target dry weight
- •KDOQI defined hypertension (predialysis SBP >140 or postdialysis SBP>130) AND
- •pre to post hemodialysis SBP increase (>10 mmHg) during 4/6 last HD session
排除标准
- •Patients with active cancer or active wounds
- •Patient currently on antibiotics or on IV antibiotics within the last month
- •BP unable to be measured by routine mechanisms in the upper extremity
- •Life expectancy < 6 months
- •Inability to provide informed consent
- •Larger interdialytic weight gain (>5 kg/treatment on average)
结局指标
主要结局
Systolic blood pressure
时间窗: crossover studies followup 3-16 weeks
Differences in blood pressure during hemodialysis between treatments
次要结局
- Endothelial cell function(crossover studies with followup of 3-16 weeks)