The purpose of the present study is to assess the role of the RenalGuard System as compared
to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and
very-high risk patients to prevent contrast-induced acute kidney injury contrast induced
acute kidney injury (CI-AKI).
Consecutive patients with chronic kidney disease, referred to our institutions for coronary
and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of
sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System
treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated
glomerular filtration rate <30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11).
In all cases iodixanol (an iso-osmolar, non ionic contrast agent) will be administered. The
primary end point is an increase of >=0.3 mg/dL in the creatinine concentration 48 hours
after the procedure.
This study will give important answers on how to prevent CI-AKI in high and very-high risk
patients undergoing contrast media exposure.