Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine
- 15 February 2018
- journal article
- research article
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 378 (7), 603-614
- https://doi.org/10.1056/nejmoa1710933
Abstract
Intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury and associated adverse outcomes after angiography without definitive evidence of their efficacy. Using a 2-by-2 factorial design, we randomly assigned 5177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo; of these patients, 4993 were included in the modified intention-to-treat analysis. The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days. Contrast-associated acute kidney injury was a secondary end point. The sponsor stopped the trial after a prespecified interim analysis. There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P=0.33). The primary end point occurred in 110 of 2511 patients (4.4%) in the sodium bicarbonate group as compared with 116 of 2482 (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P=0.62) and in 114 of 2495 patients (4.6%) in the acetylcysteine group as compared with 112 of 2498 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P=0.88). There were no significant between-group differences in the rates of contrast-associated acute kidney injury. Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury. (Funded by the U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466.)Keywords
Funding Information
- National Health and Medical Research Council of Australia
- VA Cooperative Studies Program (CSP 578)
This publication has 28 references indexed in Scilit:
- Prevention of Contrast-Induced AKIClinical Journal of the American Society of Nephrology, 2013
- Acetylcysteine for Prevention of Renal Outcomes in Patients Undergoing Coronary and Peripheral Vascular AngiographyCirculation, 2011
- Acute kidney injury following coronary angiography is associated with a long-term decline in kidney functionKidney International, 2010
- Sodium bicarbonate for prevention of contrast-induced acute kidney injury: a systematic review and meta-analysisNephrology Dialysis Transplantation, 2009
- Economic burden of contrast-induced nephropathy: implications for prevention strategiesJournal of Medical Economics, 2007
- Risk Prediction of Contrast-Induced NephropathyThe American Journal of Cardiology, 2006
- Studying the Prevention of Acute Kidney InjuryClinical Journal of the American Society of Nephrology, 2006
- N-acetylcysteine reduces contrast-associated nephropathy but not clinical events during long-term follow-upAmerican Heart Journal, 2004
- The effect of acute renal failure on mortality. A cohort analysisJAMA, 1996
- Nephrotoxicity of ionic and nonionic contrast media in 1196 patients: A randomized trialKidney International, 1995