The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Elimination half life in dependence of the degree of renal failure
研究概览
简要总结
The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.
详细描述
Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session.
In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteer or patient with renal failure
排除标准
- •pregnancy
- •withdrawal of consent
研究组 & 干预措施
dialysis
Two doses of sodium thiosulfate
干预措施: Sodium thiosulfate (Drug)
healthy volunteer
One dose of sodium thiosulfate
干预措施: Sodium thiosulfate (Drug)
结局指标
主要结局
Elimination half life in dependence of the degree of renal failure
时间窗: 0, 15, 30, 60, 180 minutes and 24 hours after application
次要结局
- Changes in acid-base parameter after application of sodium thiosulfate(0, 15, 30, 60, 180 minutes and 24 hours after application)