Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of contrast-induced acute kidney injury
研究概览
简要总结
The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.
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 (Outcomes Assessor)
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
- 否
入选标准
- •Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.
排除标准
- •contrast medium administration within the 10 days
- •end-stage renal failure requiring dialysis
- •refusal to give informed consent
研究组 & 干预措施
Sodium bicarbonate
Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
干预措施: sodium bicarbonate solution (Drug)
Saline
Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Incidence of contrast-induced acute kidney injury
时间窗: 2 days
contrast-induced acute kidney injury is defined as an increase in serum creatinine \>= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium
次要结局
- adverse clinical events(1 month)
研究者
Mauro Maioli
Medical Doctor
Ospedale Misericordia e Dolce