NCT01172353已完成3 期
Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Contrast-induced Nephropathy
研究概览
简要总结
The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •serum creatinine > 1.1 mg/dL
- •glomerular filtration rate (GFR) < 50 mL/min
排除标准
- •age < 18 years
- •use of radiographic contrast media during the last 21 days
- •history of dialysis
- •cardiac insufficiency class III-IV
- •emergency procedures
研究组 & 干预措施
saline
Active Comparator
hydration with saline 1ml/Kg/h for 6 hours
干预措施: saline (Drug)
sodium bicarbonate
Experimental
hydration with sodium bicarbonate
干预措施: sodium bicarbonate (Drug)
结局指标
主要结局
Contrast-induced Nephropathy
时间窗: 48 hours
rise in serum creatinine \>0,5mg/dl
次要结局
- Dialysis During Hospitalization(During hospitalization)
研究者
Vitor Osorio Gomes
MD, PhD
Hospital Sao Lucas da PUCRS
研究点 (1)
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