Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Brachial Artery Flow Mediated Dilation (FMD)
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- •Uncontrolled hypertension
- •Expected to undergo living related kidney transplant in next 6 months
- •Expected to start dialysis in next 3 months
- •Overt congestive heart failure
- •Use of sevelamer
- •Use of calcium carbonate
研究组 & 干预措施
A: Treatment/Control
Patients will start with sodium bicarbonate treatment then switch to control (no treatment)
干预措施: Sodium bicarbonate (Drug)
A: Treatment/Control
Patients will start with sodium bicarbonate treatment then switch to control (no treatment)
干预措施: Control (Other)
B: Control/Treatment
Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
干预措施: Sodium bicarbonate (Drug)
B: Control/Treatment
Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
干预措施: Control (Other)
结局指标
主要结局
Change in Brachial Artery Flow Mediated Dilation (FMD)
时间窗: 6 weeks and 12 weeks
The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.
次要结局
未报告次要终点