Conditions: Renal Impairment
Keywords: Renal Kidney Contrast Induced Nephropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Detailed description:
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Arms:
arm 1: Ioversol 320 mgI/mL arm 2: Iodixanol 320 mgI/mL

Interventions: intervention 1: Ioversol 320 mgI/mL intervention 2: Iodixanol 320 mgI/mL
Intervention descriptions: intervention 1: 125 mL of Ioversol administered in the vein intervention 2: 125 mL of Iodixanol administered in the vein

Protocol document: