Contrast-induced nephropathy in patients with chronic kidney disease undergoing computed tomography: a double-blind comparison of iodixanol and iopamidol
Barrett BJ, Katzberg RW, Thomsen HS, et al, for the IMPACT Study Investigators Invest Radiol 2006;41:815-821.
Objective
The aim of the IMPACT—Isovue®-370 (iopamidol injection) and Visipaque™ 320 (iodixanol injection) in renally Impaired Patients undergoing Computed Tomography—study was to prospectively compare the incidence of contrast-induced nephropathy (CIN) following intravenous (IV) administration of equal doses of iopamidol-370 and iodixanol 320.
Study Design
A double-blind, prospective, randomized, multicenter, parallel-group clinical trial in an at-risk patient
population, to compare the renal tolerability of iopamidol-370 and iodixanol 320 in a common clinical setting.
Methods:
The study enrolled 153 evaluable patients with stable, moderate-to-severe chronic kidney disease
(serum creatinine ≥1.5 mg/dL or creatinine clearance ≤60 mL/min) undergoing contrast-enhanced
multidetector CT (CE-MDCT) of the liver or peripheral arteries.
• Patients were randomized to receive equi-iodine doses 40 grams of iodine (gI) of either iopamidol-370
(370 mgI/mL) or iodixanol 320 (320 mgI/mL), both injected intravenously at 4 mL/sec
• All groups and individuals associated with the study remained blinded to the contrast agents used
• No preventative measures were taken other than IV fluids
• Serum creatinine (SCr) and creatinine clearance (CrCl) were obtained at screening, baseline, and
48–72 ±6 hours postdose (mean: 57.4 hours)
• A Renal Safety Data Monitoring Board, composed of three independent medical experts, reviewed
the renal safety data (predose and postdose SCr and CrCl values), and other necessary related data
(e.g., demographics, medical history, concomitant medications, volume supplementation, contrast dose)
of each patient in a blinded manner, to establish evaluability
• CIN was the primary endpoint, defined as an absolute increase ≥0.5 mg/dL
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media.
Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.
As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history.
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