Delayed adverse reaction to contrast-enhanced CT

A prospective single-center study comparison to control group without enhancement

Shaun Loh, Sepideh Bagheri, Richard W Katzberg, Maxwell A Fung, Chin-Shang Li

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Purpose: To prospectively assess the incidence of delayed adverse reactions (DARs) in patients undergoing contrast material-enhanced computed tomography (CT) with the low osmolar nonionic contrast agent iohexol and compare with the incidence of DARs in patients undergoing unenhanced CT as control subjects. Materials and Methods: Institutional review board approval and informed written consent for this prospective study were obtained. The study was HIPAA compliant. Patients undergoing CT for routine indications were enrolled from a random next-available scheduling template by an on-site clinical trials monitor. All subjects received a questionnaire asking them to indicate any DAR occurring later than 1 hour after their examination. Sixteen manifestations were listed and included rash, skin redness, skin swelling, nausea, vomiting, and dizziness, among others. To ensure maximal surveillance, a clinical trials coordinator initiated direct telephone contact for further assessment. Patients suspected of having moderately severe cutaneous reactions were invited to return for a complete dermatologic clinical assessment including skin biopsy, if indicated. Statistical analysis was performed by using a twosided Wilcoxon-Mann-Whitney test, a logistic regression utilizing a x2 test to adjust for sex and age, and a two-sided Fisher exact test. Results: A total of 539 patients (258 receiving iohexol and 281 not receiving contrast material) were enrolled. DARs were observed in 37 (14.3%) of 258 subjects receiving iohexol and in seven (2.5%) of 281 subjects in the control group (P<.0001, x2 test) after adjusting for sex and age. Specific manifestations of DARs that were significantly more frequent at contrast-enhanced CT were skin rash (P = .0311), skin redness (P = .0055), skin swelling (P = .0117), and headache (P = .0246). DARs involving the skin included generalized rashes of the face, neck, chest, back, and extremities and were often associated with swelling, erythema, and pruritus. Conclusion: This study substantiates a frequent occurrence of DARs at contrast-enhanced CT compared with that in control subjects. Continued growth in the use of contrast-enhanced CT suggests a need for greater awareness and attention to prevention and management.

Original languageEnglish (US)
Pages (from-to)764-771
Number of pages8
JournalRadiology
Volume255
Issue number3
DOIs
StatePublished - Jun 2010

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Tomography
Iohexol
Control Groups
Skin
Exanthema
Contrast Media
Clinical Trials
Health Insurance Portability and Accountability Act
Research Ethics Committees
Incidence
Dizziness
Erythema
Pruritus
Informed Consent
Telephone
Nausea
Vomiting
Headache
Neck
Thorax

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Delayed adverse reaction to contrast-enhanced CT : A prospective single-center study comparison to control group without enhancement. / Loh, Shaun; Bagheri, Sepideh; Katzberg, Richard W; Fung, Maxwell A; Li, Chin-Shang.

In: Radiology, Vol. 255, No. 3, 06.2010, p. 764-771.

Research output: Contribution to journalArticle

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abstract = "Purpose: To prospectively assess the incidence of delayed adverse reactions (DARs) in patients undergoing contrast material-enhanced computed tomography (CT) with the low osmolar nonionic contrast agent iohexol and compare with the incidence of DARs in patients undergoing unenhanced CT as control subjects. Materials and Methods: Institutional review board approval and informed written consent for this prospective study were obtained. The study was HIPAA compliant. Patients undergoing CT for routine indications were enrolled from a random next-available scheduling template by an on-site clinical trials monitor. All subjects received a questionnaire asking them to indicate any DAR occurring later than 1 hour after their examination. Sixteen manifestations were listed and included rash, skin redness, skin swelling, nausea, vomiting, and dizziness, among others. To ensure maximal surveillance, a clinical trials coordinator initiated direct telephone contact for further assessment. Patients suspected of having moderately severe cutaneous reactions were invited to return for a complete dermatologic clinical assessment including skin biopsy, if indicated. Statistical analysis was performed by using a twosided Wilcoxon-Mann-Whitney test, a logistic regression utilizing a x2 test to adjust for sex and age, and a two-sided Fisher exact test. Results: A total of 539 patients (258 receiving iohexol and 281 not receiving contrast material) were enrolled. DARs were observed in 37 (14.3{\%}) of 258 subjects receiving iohexol and in seven (2.5{\%}) of 281 subjects in the control group (P<.0001, x2 test) after adjusting for sex and age. Specific manifestations of DARs that were significantly more frequent at contrast-enhanced CT were skin rash (P = .0311), skin redness (P = .0055), skin swelling (P = .0117), and headache (P = .0246). DARs involving the skin included generalized rashes of the face, neck, chest, back, and extremities and were often associated with swelling, erythema, and pruritus. Conclusion: This study substantiates a frequent occurrence of DARs at contrast-enhanced CT compared with that in control subjects. Continued growth in the use of contrast-enhanced CT suggests a need for greater awareness and attention to prevention and management.",
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