A randomized trial of intravenous n-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes

Catheter Cardiovasc Interv. 2012 May 1;79(6):921-6. doi: 10.1002/ccd.23157. Epub 2011 Nov 30.

Abstract

Background: Pharmacokinetic data suggests that the intravenous form of n-acetylcysteine (NAC) may be more effective than the oral formulation in preventing contrast induced nephropathy (CIN). NAC owing to its anti-oxidant properties might be beneficial for patients with acute coronary syndromes (ACS) who are at increased risk for CIN. The aim of this prospective randomized, single-center, double-blind, placebo controlled trial (NCT00939913) was to assess the effect of high-dose intravenous NAC on CIN in ACS patients undergoing coronary angiography and/or percutaneous coronary intervention (PCI).

Methods: We randomized 398 ACS patients scheduled for diagnostic angiography ± PCI to an intravenous regimen of high-dose NAC (1,200 mg bolus followed by 200 mg/hr for 24 hr; n = 206) or placebo (n = 192). The primary end-point was incidence of CIN defined as an increase in serum creatinine concentration ≥ 25% above the baseline level within 72 hr of the administration of intravenous contrast.

Results: There was no difference found for the primary end point with CIN in 16% of the NAC group and in 13% of the placebo group (p = 0.40). Change in serum cystatin-C, a sensitive marker for renal function, was 0.046 ± 0.204 in the NAC group and 0.002 ± 0.260 in the control group (p = 0.07).

Conclusion: In ACS patients undergoing angiography ± PCI, high-dose intravenous NAC failed to reduce the incidence of CIN.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetylcysteine / administration & dosage*
  • Acute Coronary Syndrome / diagnostic imaging*
  • Acute Coronary Syndrome / therapy
  • Aged
  • Angioplasty, Balloon, Coronary*
  • Antioxidants / administration & dosage*
  • Biomarkers / blood
  • Chi-Square Distribution
  • Contrast Media / adverse effects*
  • Coronary Angiography / adverse effects*
  • Creatinine / blood
  • Cystatin C / blood
  • Double-Blind Method
  • Female
  • Humans
  • Infusions, Intravenous
  • Kidney Diseases / blood
  • Kidney Diseases / chemically induced
  • Kidney Diseases / diagnosis
  • Kidney Diseases / prevention & control*
  • Male
  • Middle Aged
  • New Orleans
  • Placebos
  • Prospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Antioxidants
  • Biomarkers
  • CST3 protein, human
  • Contrast Media
  • Cystatin C
  • Placebos
  • Creatinine
  • Acetylcysteine

Associated data

  • ClinicalTrials.gov/NCT00939913