The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CAC score
研究概览
简要总结
The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.
详细描述
Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •CAC score > 300
- •Life expectancy > 6 months
- •Dialysis vintage > 6 months
排除标准
- •Non-compliance to hemodialysis
研究组 & 干预措施
A
干预措施: 25% intravenous (IV) sodium thiosulfate (Drug)
结局指标
主要结局
CAC score
时间窗: 6 months
次要结局
- Bone mineral density, calcium removal(6 months, 1 and 2 months)