Does the use of sodium bicarbonate or acetylcysteine prevent death, need for dialysis, or worsening kidney function following angiography in patients with chronic kidney disease?

This study found no benefit of using periprocedural sodium bicarbonate or acetylcysteine to prevent death or worsening kidney function in patients with chronic kidney disease (CKD) who are undergoing angiography. Most of the patients in the trial underwent diagnostic angiography so the volume of contrast used was small and may have resulted in lower-than-predicted event rates. (LOE = 1b)

Weisbord SD, Gallagher M, Jneid H, et al, for the PRESERVE Trial Group. Outcomes after angiography with sodium bicarbonate and acetylcysteine. N Engl J Med 2017 Nov 12 [Epub ahead of print]  [PMID:29130810]

Randomized controlled trial (double-blinded)

Government

Concealed

Inpatient (any location) with outpatient follow-up

Patients with stage 3 or stage 4 CKD who were undergoing angiography were randomized, using concealed allocation and a 2-by-2 factorial design, to receive either intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride in 1 liter bags and either oral acetylcysteine capsules or matched placebo. The fluid was administered for up to 12 hours prior to angiography, continued during angiography, and maintained for up to 12 hours following angiography. The acetylcysteine or matching placebo was given as 1200-mg capsules 1 hour before and 1 hour after angiography and then twice daily for 4 days after the procedure. Almost 5000 patients were included in the modified intention-to-treat analysis, which included all patients who received the trial interventions whether or not they underwent angiography. Enrollment in the trial was stopped early due to absence of difference in the groups at a pre-planned interim analysis. Baseline characteristics were fairly similar in the 4 treatment combination groups. Ninety percent of the patients in the trial received coronary angiography with only one third of those receiving further percutaneous intervention. Median volume of contrast received was 85 mL. For the primary endpoint of death, need for dialysis, or a persistent increase in baseline creatinine level by 50% at 90 days, there was no significant difference between the sodium bicarbonate and sodium chloride groups or between the acetylcysteine and placebo groups. Contrast-induced acute kidney injury occurred in similar frequencies in all groups with no differences between the specified comparisons.