Combination N-Acetylcysteine, Sodium Bicarbonate Fails to Significantly Lower Acute CIN

MIAMI BEACH, FLA.—Combination N-acetylcysteine and sodium bicarbonate does not significantly reduce contrast-induced nephropathy within 30 days compared with standard saline hydration alone in patients with STEMI who receive primary PCI, according to data from a prospective, randomized trial.

Lisette Okkels Jensen, MD, DMSci, PhD, of Odense University Hospital in Denmark, and colleagues randomized 715 STEMI patients to either N-acetylcysteine (NAC), sodium bicarbonate, NAC plus sodium bicarbonate or standard therapy.

Within 3 days of randomization, acute contrast-induced nephropathy (CIN),defined as an increase in serum creatinine concentration >25% from baseline, occurred in numerically fewer patients treated with combination NAC and sodium bicarbonate vs. those treated with standard saline hydration, though this did not reach statistical significance (see Figure). Additionally, the combined treatment was associated with a reduced rate of CIN after 30 days (9.2% vs. 21.3%; P=.033).

Among patients with acute CIN, those with persistent nephropathy from baseline was observed in 29.6% of patients treated with combination therapy vs. 50.0% of those treated with standard therapy (P=.150). Similarly, among those without acute CIN, a late increase in serum creatinine >25% from baseline after 30 days occurred among 3.5% of patients treated with combination therapy vs. 7.4% of those treated with standard therapy (P=.322).

Study details

For the trial, Dr. Jensen and colleagues enrolled patients aged 18 or older with STEMI and primary PCI within 12 hours of symptom onset were randomly assigned in a 1:1:1:1 fashion to hydration with normal saline plus:

• Oral NAC 1,200 mg prior to primary PCI and 1,200 mg daily for 48 hours after PCI (n=176)
• Sodium bicarbonate infusion 14 g/L isotonic with 500 mL initiated during primary PCI and followed by 100 mL/hour for 5 hours (n=181)
• NAC in combination with sodium bicarbonate (n=177)
• Hydration with intravenous normal saline infusion alone (n=181).

“We will keep following these patients for a year to measure any negative outcomes in those with increased creatinine after 30 days,” Jensen said.