The PREDICT study: a randomized double-blind comparison of contrast-induced nephropathy after low- or isoosmolar contrast agent exposure.

OBJECTIVE: The objective of the PREDICT (patients with renal impairment and diabetes undergoing computed tomography) study was to compare the incidence of contrast-induced nephropathy (CIN) after administration of low-osmolar (iopamidol 370, 796 mOsm/kg) or isoosmolar (iodixanol 320, 290 mOsm/kg) contrast medium in patients with diabetes and chronic kidney disease undergoing CT. SUBJECTS AND METHODS: Two hundred sixty-three patients with moderate to severe chronic kidney disease (estimated glomerular filtration rate [GFR] = 20-59 mL/min/1.73 m(2)) and diabetes mellitus were randomized to receive at least 65 mL of iopamidol 370 or iodixanol 320 for a CT procedure. Serum creatinine levels were measured at baseline and 48-72 hours after contrast administration. CIN was defined as an increase in the serum creatinine level after contrast administration of >or= 25% from the baseline level. The incidence of CIN in the total study population and the incidence of CIN in patients at increased risk for CIN were compared using Fisher's exact test.
RESULTS: Two hundred forty-eight patients were included in the CIN analysis: 125 receiving iopamidol 370 and 123 receiving iodixanol 320. Study population demographics were comparable, as was baseline renal function (estimated GFR = 47.6 mL/min/1.73 m(2) for the iopamidol 370 group vs 49.9 mL/min/1.73 m(2) for the iodixanol 320 group; p = 0.16). Increases in the serum creatinine value of >or= 25% occurred in seven patients (5.6%) receiving iopamidol 370 and in six patients (4.9%) receiving iodixanol 320 (95% CI, -4.8% to 6.3%; p = 1.0). The mean serum creatinine change from the baseline level was 0.04 mg/dL in both groups (analysis of covariance, p = 0.80). In patients with a baseline serum creatinine value of >or= 2.0 mg/dL, baseline estimated GFR of <or= 40 mL/min/1.73 m(2), or those receiving > 140 mL of contrast medium, the incidence of CIN was low and comparable between the two study groups (p = 1.0 in all instances).
CONCLUSION: The incidence of CIN in patients with diabetes and chronic kidney disease receiving IV contrast medium was not significantly different after CT using iopamidol 370 or iodixanol 320.

RCT Entities:   Population Interventions Outcomes