Study Design

Study Design:

Patients Enrolled: 129
Mean Follow Up: 7 days
Mean Patient Age: mean 71 years
Female: 27

Patient Populations:

Age >18 years, referred for coronary or aortofemoral angiography, diabetes (type 1 or 2) being treated with insulin or oral antidiabetic drugs, and either a stable serum creatinine concentration (1.5-3.5 mg/dL for men and 1.3-3.5 mg/dL for women) within 3 months before enrollment or a calculated creatinine clearance <=60 ml/min.

Exclusions:

Pregnancy, lactation, IV administration of an iodinated contrast medium in prior 7 days, treatment with metformin or nonsteroidal anti-inflammatory drugs in prior 48 hours, use of nephrotoxic drugs in prior 7 days, history of serious reactions to iodinated contrast agents, newly discovered unstable diabetes, severe concomitant disease, renal transplantation, or end-stage renal disease necessitating dialysis.

Primary Endpoints:

Peak increase from baseline in the creatinine concentration during the 3 days after angiography

Secondary Endpoints:

Number of patients with a peak increase of >=0.5 mg/dL and the number with a peak increase of >=1.0 mg/dL during days 0 through 3; change in the serum creatinine concentration from day 0 to day 7

Drug/Procedures Used:

Patients were randomized to the nonionic, iso-osmolar, dimeric contrast medium, iodixanol (320 mg of iodine per mL; 290 mOsm per kg of water) (n=64) or the nonionic, low-osmolar, monomeric contrast medium iohexol (350 mg of iodine per mL; 780 mOsm per kg of water) (n=65). Serum creatinine was measured at baseline and days 2, 3, and 7.

Concomitant Medications:

Recommended (but not required): 500 ml of water orally, 500 ml of saline IV, or both before angiography and 1 liter of 0.9% saline or similar fluids IV from the start of the procedure.