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临床试验/NCT04606056
NCT04606056进行中(未招募)不适用

A Single Center Observational Study- Incidence and Risk Factors of Acute Kidney Injury After Intravenous Contrast Enhanced Computed Tomography Scans

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5,000
试验地点
1
主要终点
Incidence of acute kidney injury

研究概览

简要总结

Intravenous iodinated contrast media is commonly used to enhance diagnostic yield of computer tomography (CT) scans in clinical medicine. However, the perceived risk of contrast-induced nephropathy (CIN) frequently limits its use. While CIN is often self-limiting, it can cause significant morbidity by prolonging admissions and rendering an at-risk individual dialysis dependent. CIN has long been observed and described in clinical studies. There is ample data on CIN after administration of intraarterial contrast, but evidence is less compelling when it comes to intravenous contrast. Increasing studies have called into question the actual risk of intravenous contrast media. Expert panels are suggesting that the risk could have been overstated, leading to contrast being withheld when indicated. There is paucity of local data on this particular issue. More real world data on the actual incidence and risk factors of AKI will be helpful to clinicians.

The investigators plan to conduct a single center, retrospective study, to determine the incidence and risk factors of post contrast AKI in contrast enhanced CT scans.

详细描述

A single center, retrospective study will be conducted, looking into all patients who had contrast-enhanced CT scans done in a specified time period. Serum creatinine at baseline and at 48-72 hours post-contrast of the participants will be compared to determine presence of post contrast AKI (PC-AKI). Data on the participants' demographics, comorbidities, laboratory results and use of nephrotoxins will also be captured and analysed.

The primary objective of this study is to determine the incidence of AKI after intravenous contrast administration for contrast enhanced CT scans (CECT). The secondary objective is to identify risk factors of PC-AKI and possibly come up with a risk stratification system that can be utilized in clinical practice. The investigators hypothesize that there is significant risk of acute kidney injury after intravenous contrast media administration, but it lower than that in the setting of intraarterial contrast; and that risk factors of AKI may include: pre existing chronic kidney disease, diabetes, hypertension, proteinuria, use of nephrotoxins, age, increased dose of contrast.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
13 Years 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Underwent one or more CT scan in CGH in the stipulated study period
  • CT scan done as an inpatient or outpatient of CGH
  • Serum creatinine available less than 6 months before scan
  • Serum creatinine available within 1 week after scan

排除标准

  • Age 12 or below
  • Dialysis dependent before scan (dialysis related charge code applied 24 months before scan)
  • Baseline serum creatinine not available
  • Post scan serum creatinine not available

结局指标

主要结局

Incidence of acute kidney injury

时间窗: 31 May 2020 to 30 June 2020

within 1 week after contrast exposure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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