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Safety of non-ionic contrast media in CT examinations for out-patients: retrospective multicenter analysis of 473,482 patients

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Abstract

Objectives

This study aimed to explore the incidence of and potential risk factors for adverse drug reactions (ADRs) after non-ionic iodinated contrast media (NICM) administration for CT exams in out-patient settings in China.

Materials and methods

A total of 473,482 out-patients who underwent intravenous NICM between January 1st, 2017, and Dec 31st, 2021, were retrospectively enrolled from three institutions. The occurrence of ADRs and clinical information were recorded. Chi-square test, Poisson regression, and logistic regression analyses were used to evaluate potential ADR risk factors and correlation with demographics, season, and NICM type.

Results

Among the 473,482 patients (mean age 55.22 ± 14.85; 253,499 male) who received intravenous NICM, the overall ADR incidence was 0.110% (522 of 473,482), with 0.099% acute-related drug reactions (469 of 473,482) and 0.0004% serious ADRs (two of 473,482). Iopromide was associated with a higher risk of acute ADRs. Late ADRs were more frequently observed with iodixanol 320. Multi-level logistic regression of patients with acute ADRs and a control group (matched 1:1 for age, gender, NICM, prescriber department, and institution) showed that summer (adjusted OR = 1.579; p = 0.035) and autumn (adjusted OR = 1.925; p < 0.001) were risk factors of acute ADRs. However, underlying disease and scanned body area were not related to a higher ADR incidence.

Conclusion

The use of NICM for out-patients is in general safe with a low ADR incidence. The type of contrast medium (iopromide) and the seasons (summer and autumn) were associated with a higher risk of acute ADRs. Late ADRs were more often observed with iodixanol.

Clinical relevance statement

In comparison to in-patients, out-patients may be exposed to higher risk due to a lack of extensive risk screening, less nursing care, and higher throughput pressure. Safety data about NICM from a large population may complement guidelines and avoid ambiguity.

Key Points

• The incidence and risk factors for adverse events after using non-ionic iodinated contrast media are complex in out-patients.

• Non-ionic iodinated contrast media are safe for out-patients and the overall incidence of adverse drug reactions was 0.110%.

• There is a higher risk of acute adverse drug reactions in summer and autumn.

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Abbreviations

ADR:

Adverse drug reaction

AE:

Adverse events

ESUR:

European Society of Urogenital Radiology

NICM:

Non-ionic iodinated contrast media

OR:

Odds ratio

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Acknowledgements

The authors would like to thank Processor Cairong Zhu, Hanming Xu, Qiang Yao, and Meijing Hu of the West China School of Public Health for their excellent support on data analysis.

Funding

This study has received funding by the Science and Technology Support Program of Sichuan Province (2021YFG0137).

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Author notes

  1. Wen Zeng and Jing Tang have equal contributions to this article.

Authors and Affiliations

  1. Department of Radiology, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, Sichuan, China

    Wen Zeng, Jing Tang, Xu Xu, Yu Zhang, Lingming Zeng, Yiteng Zhang, Zejun Liang, Chunchao Xia, Lihong Zhao & Zhenlin Li

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  1. Wen Zeng
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Correspondence to Lihong Zhao or Zhenlin Li.

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Guarantor

The scientific guarantor of this publication is Zhenlin Li.

Conflict of interest

The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

Statistics and biometry

Processor Cairong Zhu kindly provided statistical advice for this manuscript.

Informed consent

Written informed consent was not required for this study because this is a retrospective study.

Ethical approval

Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

No study subjects or cohorts have been previously reported.

Methodology

• retrospective

• cross-sectional study

• multicenter study

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Zhenlin Li and Lihong Zhao are co-corrresponding authors.

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Zeng, W., Tang, J., Xu, X. et al. Safety of non-ionic contrast media in CT examinations for out-patients: retrospective multicenter analysis of 473,482 patients. Eur Radiol (2024). https://doi.org/10.1007/s00330-024-10654-2

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