Renal Insufficiency Clinical Trial
Official title:
Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.
Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a
contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected
for inclusion. Two groups of patients were defined on the basis of the planned imaging
procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those
undergoing an unenhanced MRI.
A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI
exam was used as an indication of contrast induced nephrotoxicity. A blood test was
performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the
exam, a second blood test was performed. An increase in creatinemia above 25% from baseline
levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the
study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction
in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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