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
| Autor: | Thomsen, Hs, Morcos, Sk, Erley, Cm, Grazioli, L, Bonomo, L, Ni, Z, Romano, L, Bader, T, Benea, G, Catalano, C, Chen, Km, Feng, Xy, Hellström, M, Morana, Giovanni, POZZI MUCELLI, Roberto, Reimer, P, Tasu, Jp, Wright, A, Yang, L. |
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| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty iomeprol iodixanol Iomeprol Contrast-induced nephropathy Contrast Media Renal function Kidney Function Tests chronic kidney disease computed tomography contrast-induced nephropathy Risk Assessment Iopamidol law.invention chemistry.chemical_compound Double-Blind Method Randomized controlled trial Risk Factors law Triiodobenzoic Acids medicine Humans Radiology Nuclear Medicine and imaging Aged Creatinine business.industry General Medicine medicine.disease Iodixanol Surgery Radiographic Image Enhancement chemistry Injections Intravenous Kidney Failure Chronic Nephrosis Female Radiology Tomography X-Ray Computed business medicine.drug Kidney disease |
| Popis: | 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)or =1.5 mg/dL (132.6 micromol/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 ofor =0.5 mg/dL (44.2 micromol/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 micromol/L) in the iomeprol-400 group and 1.7 +/- 0.7 mg/dL (150.3 +/- 61.9 micromol/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 ofor =0.5 mg/dL (44.2 micromol/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. |
| Databáze: | OpenAIRE |
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