Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
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 induced 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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention
排除标准
- •refusal to consent
- •previous contrast exposure within 72 hours
研究组 & 干预措施
1
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)
2
Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure
干预措施: Isotonic saline (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
时间窗: within 5 days after contrast exposure
次要结局
- Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration(1 month)
研究者
Mauro Maioli
MD
Ospedale Misericordia e Dolce