NCT00292487已完成4 期
Isovue and Visipaque in Renally Impaired Patients Undergoing CT
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Increase in SCr at 48-72 hours post dose
研究概览
简要总结
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •referred for MDCT of liver or peripheral CTA
- •stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min
排除标准
- •unstable renal function
- •required prophylactic drugs to receive contrast (other than hydration)
- •uncontrolled diabetes
- •currently on dialysis
结局指标
主要结局
Increase in SCr at 48-72 hours post dose
次要结局
- Compare incidence of delayed hypersensitivity type reactions
- Compare changes in heart rate
- Compare efficacy of key vessels
研究者
研究点 (2)
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