NCT04024514进行中（未招募）不适用
Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Overall image quality
研究概览
简要总结
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk group for developing HCC
- •Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
- •chronic kidney disease (Estimated GFR < 60mL/min/1.73m2)
排除标准
- •not a high risk group for developing HCC
- •congestive hepatopathy
- •on dialysis
- •no venous access on forearm
- •anticipated beam hardening artifact due to prosthesis
- •relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR < 60mL/min/1.73m2)
结局指标
主要结局
Overall image quality
时间窗: 6 months after complete enrollment
qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)
次要结局
- Lesion conspicuity(12 months after complete enrollment)
- lesion (HCC) detection(12 months after complete enrollment)
- Incidence of Contrast media-induced nephrotoxicity(3 days after contrast media administration)
- Contrast media (CM) dose(3 months after complete enrollment)
- Image contrast(12 months after complete enrollment)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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