NCT07231900尚未招募2 期
Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Chronic hemodialysis patient > 3 months
- •3 dialysis per week, KTV>1.2
- •capable of informed concent.
- •rise in blood pressure during hemodialysis > 10 mm Hg, for at least 50% of dialysis sessions in the month prior to inclusion.
- •Normal volume status, by clinical physician assessment + bioimpedance
排除标准
- •age under 18,
- •pregnancy
- •unable to sign informed concent
- •planned for kidney transplant in the following 3 month.
- •congestive heart failure (NYHA 3-4)
- •hospitalization for acute MI or CHF in the past 3 months.
- •low compliece to medical therapy
- •regular pre-dialysis tests with bicarbonate > 24 in the past 3 months
研究组 & 干预措施
Sodium bicarbonate
Experimental
PO Sodium bicarbonate 500mg X2/day
干预措施: Sodium Bicarbonate (NaHCO3) (Drug)
Placebo
Placebo Comparator
1 tab X2/day
干预措施: Placebo (Drug)
结局指标
主要结局
Blood pressure
时间窗: 1 month
Prevention of intra dialytic hypertension
次要结局
未报告次要终点
研究者
Shani Zilberman Itskovich
Dr.
Assaf-Harofeh Medical Center
研究点 (1)
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