NCT00494637终止不适用
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
Lenox Hill Hospital0 个研究点目标入组 468 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 468
- 主要终点
- Incidence of contrast induced nephropathy
研究概览
简要总结
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •serum creatinine greater then or equal to 1.5
排除标准
- •Overt CHF
- •Alkalemia
- •Hypokalemia
- •GFR<20 cc/min
结局指标
主要结局
Incidence of contrast induced nephropathy
时间窗: 48-72 hours
次要结局
未报告次要终点
研究者
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