title: Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Radiology Department, CHU Charles Nicolle, Rouen, France. zoo_ci@yahoo.fr
authors.forename: Martin
authors.initials: M
authors.lastname: Zo'o
authors.forename: Marcus
authors.initials: M
authors.lastname: Hoermann
authors.forename: Csilla
authors.initials: C
authors.lastname: Balassy
authors.forename: Francis
authors.initials: F
authors.lastname: Brunelle
authors.forename: Robin
authors.initials: R
authors.lastname: Azoulay
authors.forename: Danièle
authors.initials: D
authors.lastname: Pariente
authors.forename: Michel
authors.initials: M
authors.lastname: Panuel
authors.forename: Patrick
authors.initials: P
authors.lastname: Le Dosseur
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects / Q000494:pharmacology / Q000592:standards*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000592:standards; D007668:Kidney / Q000000981:diagnostic imaging* / Q000187:drug effects; D007674:Kidney Diseases / Q000139:chemically induced / Q000150:complications / Q000000981:diagnostic imaging; D008297:Male; D061330:Multidetector Computed Tomography; D014283:Triiodobenzoic Acids / Q000009:adverse effects / Q000494:pharmacology / Q000592:standards*
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; C093233:iobitridol; D007472:Iohexol; C044834:iodixanol