Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight at Abdominal CT: a North American Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
研究概览
简要总结
The purpose of this study is to evaluate the effect of dosing iodinated contrast media according to a patient's total body weight vs. lean body weight. Participants will be randomized into 2 groups based on contrast dosing technique, and solid organ enhancement at uniphasic abdominal CT will be measured.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •outpatients only
- •patients scanned on modern Siemens scanners at our institution
排除标准
- •self-reported history of chronic kidney, heart or liver disease
- •allergy to iodinated contrast
- •acute illness
- •outside maximum threshold limit for weight-based contrast dosing
- •pregnancy
- •image degradation
研究组 & 干预措施
Lean Body Weight
干预措施: Iohexol (Drug)
Total Body Weight
干预措施: Iohexol (Drug)
结局指标
主要结局
Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
时间窗: 1 hour
Images of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography (CT) images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. This will provide a measure of liver enhancement.
次要结局
- Standard deviation in mean hepatic enhancement (sigma MHE): standard deviation in the difference in liver attenuation on CT acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)(1 hour)
研究者
Andreu Costa
Principal Investigator; Section Head of Abdominal Radiology, Queen Elizabeth II Health Sciences Centre; Assistant Professor, Dalhousie University
Nova Scotia Health Authority