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Open Access 01-11-2011 | Original Article

Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT

Authors: Martin Zo’o, Marcus Hoermann, Csilla Balassy, Francis Brunelle, Robin Azoulay, Danièle Pariente, Michel Panuel, Patrick Le Dosseur

Published in: Pediatric Radiology | Issue 11/2011

Abstract

Background

It is debated whether iso-osmolar and low-osmolar contrast media are associated with different incidences of contrast medium-induced nephropathy (CIN) in patients with renal insufficiency.

Objective

To compare the incidence of CIN in children undergoing contrast-enhanced multidetector computer tomography (MDCT) with intravenous injection of low-osmolar (iobitridol, Xenetix® 300) or an iso-osmolar (iodixanol, Visipaque® 270) iodinated contrast medium.

Materials and methods

One hundred forty-six children with normal renal function were included in this multicenter trial and underwent contrast-enhanced MDCT. The primary endpoint was the relative change in creatinine clearance from 48 h pre- to 72 h postcontrast medium administration using a noninferiority analysis in the intent-to-treat (ITT, n = 128) and per protocol (n = 68) populations. Secondary endpoints were incidence of CIN, global image quality, diagnostic efficacy and clinical safety.

Results

In the ITT population, the noninferiority of iobitridol over iodixanol was demonstrated. CIN incidence was 4.8% (three cases) with iobitridol and 10.6% (seven cases) with iodixanol (not significant). No statistically significant differences were observed for the secondary endpoints.

Conclusion

Comparable satisfactory safety profiles were confirmed for both contrast media, with no significant difference in the incidence of CIN in children with normal renal function.

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Title: Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT
Authors: Martin Zo’o
Marcus Hoermann
Csilla Balassy
Francis Brunelle
Robin Azoulay
Danièle Pariente
Michel Panuel
Patrick Le Dosseur
Publication date: 01-11-2011
Publisher: Springer-Verlag
Published in: Pediatric Radiology / Issue 11/2011
Print ISSN: 0301-0449
Electronic ISSN: 1432-1998
DOI: https://doi.org/10.1007/s00247-011-2164-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT

Abstract

Background

Objective

Materials and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Materials and methods

Results

Conclusion

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