Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Occurrence of Contrast-induced Nephropathy
研究概览
简要总结
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
详细描述
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an emergent coronary procedure(within 60 minutes from admission)
排除标准
- •On dialysis
- •Pregnancy
- •Past use of bicarbonate or N-Acetyl-Cystein in 48hr
- •Past exposure to contrast media in 48hr
- •Circulatory insufficiency with lactic acidosis.
研究组 & 干预措施
Sodium bicarbonate
干预措施: Sodium bicarbonate (Drug)
Sodium chloride
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
Occurrence of Contrast-induced Nephropathy
时间窗: after procedure and 1,2-3day after procedure
The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase \>0.5 mg/dl or \>25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.
次要结局
未报告次要终点