Randomized trial of bicarbonate or saline study for the prevention of contrast-induced nephropathy in patients with CKD

Abstract

Background and objectives Sodium bicarbonate has been proposed for protection of the kidney from contrastinduced AKI (CIAKI). However, the effects of bicarbonate on long-term important clinical outcomes are uncertain. Design, setting, participants, & measurements In a prospective, double-blind, multicenter randomized clinical trial, 391 patientswith an eGFR,45ml/min per 1.73m2 undergoing elective coronary or peripheral angiography were randomized to an infusionwith a high dose of isotonic sodiumbicarbonate (target 2.0mEq/kg) or a similar molar amount of isotonic sodium chloride. The primary outcome was a composite of mortality, dialysis, or a sustained 20% reduction in eGFR at 6 months. Results There were 391 patients enrolled between March 2010 and May 2012. The incidence of the primary outcome was 14.9% in the bicarbonate group and 16.3% in the control group in the intention-to-treat population (P=0.78). There was also no difference in the incidence of CIAKI between the treatment groups (14.5% versus 12.1%, respectively; P=0.20). CIAKIwas associatedwith a higher incidence of sustained loss of kidney function at 6 months compared with those without CIAKI (21.2% versus 7.7%, respectively; P=0.06). Conclusions High-dose sodium bicarbonate infusion in patients with eGFR,45 ml/min per 1.73 m2 undergoing angiography did not demonstrate a difference in incidence of the composite of death, dialysis, or sustained 6-month reduction in eGFR or CIAKI compared with sodium chloride.