NCT00606827已完成4 期
Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography
Ospedale Misericordia e Dolce1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with creatinine clearance < 60 mL/min
排除标准
- •contrast medium administration within the previous 10 days
- •end-stage renal failure requiring dialysis
- •refusal to give informed consent
研究组 & 干预措施
A
Experimental
Bicarbonate
干预措施: Sodium Bicarbonate (Drug)
B
Active Comparator
Saline
干预措施: Isotonic Saline (Drug)
研究者
Mauro Maioli
MD
Ospedale Misericordia e Dolce
研究点 (1)
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