Rationale and Objectives. We compared the safety and efficacy of iodix
anol, a nonionic, dimeric, iodinated contrast agent, with that of iohe
xol, a monomeric agent, in adult excretory urography. Methods. The stu
dy used a randomized, double-blind, parallel-comparison design to eval
uate image quality, vital signs, laboratory values, and adverse reacti
ons. Seventy-five patients from each of two centers were included. One
third received iodixanol at 270 mg I/ml, one third received iodixanol
at 320 mg I/ml, and one third received iohexol at 309 mg I/ml. The do
se for every patient was 1 ml/kg of body weight. The radiographs were
interpreted and evaluated for quality by the primary investigator at e
ach center. There were no important differences among the three groups
in terms of demographics. Results. Evaluation of each phase of the ra
diographic study showed almost uniform good-to-excellent opacification
, with no significant differences among the three agents. No significa
nt differences existed for tile three groups in terms of vital signs,
hematology, blood and urine chemistry, and injection discomfort. There
were no deaths or serious reactions during the study, nor was there a
statistically significant difference among the number of adverse even
ts for the three agents. Conclusion. Iodixanol at both 270 and 320 mg
I/ml proved to be a safe and effective contrast material for intraveno
us urography. In this study, its profile was essentially indistinguish
able from that of iohexol at 300 mg I/ml.