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




Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT - Download this document for free, or read online. Document in PDF available to download.

Pediatric Radiology

, 41:1393

First Online: 29 June 2011Received: 17 August 2010Revised: 11 February 2011Accepted: 04 April 2011

Abstract

BackgroundIt 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.

ObjectiveTo 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 methodsOne 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.

ResultsIn 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.

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

KeywordsContrast medium-induced nephropathy Multidetector computer tomography Iobitridol Iodixanol  Download fulltext PDF



Author: Martin Zo’o - Marcus Hoermann - Csilla Balassy - Francis Brunelle - Robin Azoulay - Danièle Pariente - Michel Panuel - P

Source: https://link.springer.com/







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