NCT00289614已完成4 期
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Increase in serum creatinine (SCr) at 48-72 hours post dose
研究概览
简要总结
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine 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
- 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 contrast enhanced MDCT
- •Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
- •Diagnosed as having diabetes mellitus
排除标准
- •Unstable renal function
- •Unstable diabetes
- •Concurrent administration of nephrotoxic drugs
- •Undergoing dialysis
结局指标
主要结局
Increase in serum creatinine (SCr) at 48-72 hours post dose
次要结局
- Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events
研究者
研究点 (2)
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