Steven D Weisbord1, Martin Gallagher1, Hani Jneid1, Santiago Garcia1, Alan Cass1, Soe-Soe Thwin1, Todd A Conner1, Glenn M Chertow1, Deepak L Bhatt1, Kendrick Shunk1, Chirag R Parikh1, Edward O McFalls1, Mary Brophy1, Ryan Ferguson1, Hongsheng Wu1, Maria Androsenko1, John Myles1, James Kaufman1, Paul M Palevsky1. 1. From the Veterans Affairs (VA) Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh (S.D.W., P.M.P.); University of Sydney (M.G.) and the George Institute for Global Health, University of New South Wales (M.G., A.C.), Sydney, and the Menzies School of Health Research, Darwin, NT (A.C.) - all in Australia; Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston (H.J.); Minneapolis VA Health Care System and University of Minnesota, Minneapolis (S.G., E.O.M.); VA Cooperative Studies Program Coordinating Center (S.S.T., M.B., R.F., H.W., M.A., J.M., J.K.) and the Cardiology Section (D.L.B.), VA Boston Healthcare System, and Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School (D.L.B.) - all in Boston; VA Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, NM (T.A.C.); Stanford University Department of Medicine, Palo Alto (G.M.C.), and San Francisco VA Medical Center and University of California, San Francisco, San Francisco (K.S.) - all in California; and the VA Connecticut Healthcare System and Program of Applied Translational Research, Yale University, New Haven (C.R.P.).
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 .).
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 .).
Authors: Ciara M Shaver; Melinda G Paul; Nathan D Putz; Stuart R Landstreet; Jamie L Kuck; Lauren Scarfe; Nataliya Skrypnyk; Haichun Yang; Fiona E Harrison; Mark P de Caestecker; Julie A Bastarache; Lorraine B Ware Journal: Am J Physiol Renal Physiol Date: 2019-07-31
Authors: Rohit J Timal; Judith Kooiman; Yvo W J Sijpkens; Jean-Paul P M de Vries; Iris J A M Verberk-Jonkers; Harald F H Brulez; Marjolijn van Buren; Aart J van der Molen; Suzanne C Cannegieter; Hein Putter; Wilbert B van den Hout; J Wouter Jukema; Ton J Rabelink; Menno V Huisman Journal: JAMA Intern Med Date: 2020-04-01 Impact factor: 21.873
Authors: Chirag R Parikh; Caroline Liu; Maria K Mor; Paul M Palevsky; James S Kaufman; Heather Thiessen Philbrook; Steven D Weisbord Journal: Am J Kidney Dis Date: 2019-09-20 Impact factor: 8.860