Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
研究概览
简要总结
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.
DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.
Patients will be randomised to:
- Standard treatment
- Standard treatment + acetylcystein for 2 days
- Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
- Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •STEMI patients treated with primary PCI
排除标准
- •Cardiogenic shock
研究组 & 干预措施
Standard treatment
Hydration
干预措施: Hydration (Other)
Combined Acetylcystein and Sodium Bicarbonat
干预措施: Combined Acetylcystein and Sodium Bicarbonate (Drug)
Sodium Bicarbonate
干预措施: Sodium bicarbonate (Drug)
Acetylcystein for 2 days
Standard treatment + acetylcystein for 2 days
干预措施: Acetylcysteine (Drug)
结局指标
主要结局
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
时间窗: from baseline to day 3
Rise in creatinine \>25% from baseline to day 3
次要结局
- Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI(from baseline to day 30)
研究者
Lisette Okkels Jensen
MD DMSci PhD
Odense University Hospital