A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-enhanced Computed Tomography
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Guerbet
- 入组人数
- 6
- 试验地点
- 13
- 主要终点
- Percentage of Patients With Contrast-induced Nephropathy (CIN)
研究概览
简要总结
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
详细描述
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, 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
- •Males and females 18 years of age or older
- •Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
- •Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
- •Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
- •Subjects must provide written consent and agree to abide by the site and study requirements
排除标准
- •Subjects previously entered into this study
- •Subjects on dialysis
- •Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
- •Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
- •Subjects in acute renal failure or have one or more known causes of acute renal failure
- •Subjects have known or suspected unstable renal function
- •Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
- •Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
- •Subjects taking aminoglycosides
- •Subjects known to have an organ transplantation
- •Subjects have severe congestive heart failure (Class III-IV)
研究组 & 干预措施
1
Ioversol 320 mgI/mL
干预措施: Ioversol 320 mgI/mL (Drug)
2
Iodixanol 320 mgI/mL
干预措施: Iodixanol 320 mgI/mL (Drug)
结局指标
主要结局
Percentage of Patients With Contrast-induced Nephropathy (CIN)
时间窗: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration
Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.
次要结局
未报告次要终点