Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Slope of LDR (as assessed by serum cystatin-C changes)
研究概览
简要总结
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
详细描述
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients candidate to coronary angiography and/or angioplasty and
- •Baseline creatinine clearance < 60 ml/min
排除标准
- •Patients with STEMI
- •Patients with shock
- •Known allergy to contrast media
- •Prior contrast administration within 1 month
- •Current use of nonsteroidal anti-inflammatory drugs
研究组 & 干预措施
Iodixanol
Patients randomized to coronary angiography/angioplasty with Iodixanol 320
干预措施: Iodixanol 320 (Drug)
Iobitridol
Patients randomized to coronary angiography/angioplasty with Iobitridol 350
干预措施: Iobitridol 350 (Drug)
结局指标
主要结局
Slope of LDR (as assessed by serum cystatin-C changes)
时间窗: 48 hours
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
次要结局
- Slope of LDR (as assessed by serum creatinine changes)(72 hours)
研究者
Ugo Limbruno
MD, PhD
Azienda Sanitaria Locale 9, Grosseto