The ACTIVE Trial: Comparison of the Effects on Renal Function of Iomeprol-400 and Iodixanol-320 in Patients With Chronic Kidney Disease Undergoing Abdominal Computed Tomography
- 1 March 2008
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Investigative Radiology
- Vol. 43 (3), 170-178
- https://doi.org/10.1097/rli.0b013e31815f3172
Abstract
We performed a multicenter, double-blind, randomized, parallel-group study to compare the renal effects of iomeprol-400 and iodixanol-320 in patients with preexisting chronic kidney disease undergoing contrast-enhanced multidetector computed tomography of the liver. One hundred forty-eight patients with moderate-to-severe chronic kidney disease, ie, serum creatinine (SCr) ≥1.5 mg/dL (132.6 μmol/L) and/or calculated creatinine clearance (CrCl) <60 mL/min, undergoing contrast-enhanced multidetector computed tomography of the liver were randomized to equi-iodine doses (40 gI) of either the low-osmolar agent iomeprol-400 (400 mgI/mL, 726 mOsm/kg, N = 76) or the isotonic agent iodixanol-320 (320 mgI/mL, 290 mOsm/kg, N = 72), injected intravenously at 4 mL/S, followed by a bolus of 20 mL normal saline solution at the same rate. SCr was obtained at screening, baseline and at 48 to 72 hours postdose. SCr measurements and CrCl calculations were performed by a central laboratory. Contrast-induced nephropathy (CIN) was defined as an absolute SCr increase of ≥0.5 mg/dL (44.2 μmol/L) from baseline to 48 to 72 hours postdose. Mean SCr changes from baseline were also assessed. A Renal Safety Review Board comprised 3 medical experts reviewed the renal safety data, demographics, medical history, CIN risk factors, concomitant medications, and hydration status of each subject in a blinded manner. The 2 study groups were comparable with regard to age, gender distribution, concomitant nephrotoxins, hydration status, and total iodine dose; however, the iomeprol-400 group showed a significantly higher proportion of patients with diabetes mellitus (P = 0.02). Baseline SCr was 1.7 ± 0.6 mg/dL (150.3 ± 53.0 μmol/L) in the iomeprol-400 group and 1.7 ± 0.7 mg/dL (150.3 ± 61.9 μmol/L) in the iodixanol-320 group (P = 0.87). Predose CrCl was 41.5 ± 13.1 mL/Min in the iomeprol-400 group and 43.0 ± 13.3 mL/Min in the iodixanol-320 group (P = 0.49). Five of 72 patient receiving iodixanol-320 (6.9%) and none of the patients receiving iomeprol-400 showed an increase of ≥0.5 mg/dL (44.2 μmol/L) from baseline [P = 0.025, 95% CI (−12.8%, −1.1%)]. The mean SCr change from baseline was significantly higher (P = 0.017 ANCOVA) after iodixanol-320 (0.06 ± 0.27) than after iomeprol-400 (−0.04 ± 0.19). The incidence of CIN was significantly higher after IV administration of iodixanol-320 than iomeprol-400. The mean rise in SCr from baseline was also higher in patients receiving iodixanol.Keywords
This publication has 28 references indexed in Scilit:
- Cardiac Angiography in Renally Impaired Patients (CARE) StudyCirculation, 2007
- Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Computed TomographyInvestigative Radiology, 2006
- Contrast Media and NephropathyInvestigative Radiology, 2006
- A Meta-Analysis of the Renal Safety of Isosmolar Iodixanol Compared With Low-Osmolar Contrast MediaJournal of the American College of Cardiology, 2006
- The role of osmolality in the incidence of contrast-induced nephropathy: A systematic review of angiographic contrast media in high risk patientsKidney International, 2005
- Nephrotoxicity of low-osmolality versus iso-osmolality contrast agents: Impact of N-acetylcysteineKidney International, 2005
- Effect of nonionic radiocontrast agents on the occurrence of contrast-induced nephropathy in patients with mild-moderate chronic renal insufficiency: Pooled analysis of the randomized trialsCatheterization and Cardiovascular Interventions, 2005
- Determinants of Serum Creatinine Trajectory in Acute Contrast NephropathyJournal of Interventional Cardiology, 2002
- The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiencyJournal of the American College of Cardiology, 2000
- Prediction of Creatinine Clearance from Serum CreatinineNephron, 1976