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临床试验/NCT05716568
NCT05716568已完成不适用

Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta: A Prospective Study Based on Patient Heart Rate and Body Surface Area Differences

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 60 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Reduction in contrast dose

研究概览

简要总结

An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.

详细描述

Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.

For this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.

An in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.

A total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring CT-angiography of the aorta as requested by clinician
  • For aneurysm detection or follow-up
  • Or for dissection follow-up
  • Thoraco-abdominal aorta or abdominal aorta

排除标准

  • Contra-indications for contrast administration (severe renal impairment or adverse reactions)
  • Previously endovascular repair of the aorta
  • Only thoracic aorta
  • No informed consent
  • Contrast injection at 4cc/second not possible

结局指标

主要结局

Reduction in contrast dose

时间窗: Through study completion, an average of 1 year

Reduction in contrast dose while maintaining image quality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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