03649nas a2200589   4500000000100000008004100001653001100042653001100053653000900064653002400073653000900097653002200106653001600128653001700144653001900161653002400180653001500204653002500219653002700244653001800271653003300289653002000322653001900342653001600361653001900377653002300396100001700419700001400436700001800450700002000468700001500488700002000503700001800523700001600541700001800557700001700575700001900592700001900611700001600630700001800646700001700664700002100681700001500702700001800717700001800735700002500753245007500778300001200853490000800865520217200873022001403045       2018                            d10aFemale10aHumans10aAged10aDouble-Blind Method10aMale10aTreatment Outcome10aMiddle Aged10aRisk Factors10aRenal Dialysis10aAcute Kidney Injury10aCreatinine10aAdministration, Oral10aInfusions, Intravenous10aFluid Therapy10aRenal Insufficiency, Chronic10aSodium Chloride10aAcetylcysteine10aAngiography10aContrast Media10aSodium Bicarbonate1 aGallagher M.1 aCass Alan1 aParikh Chirag1 aWeisbord Steven1 aJneid Hani1 aGarcia Santiago1 aThwin Soe-Soe1 aConner Todd1 aChertow Glenn1 aBhatt Deepak1 aShunk Kendrick1 aMcFalls Edward1 aBrophy Mary1 aFerguson Ryan1 aWu Hongsheng1 aAndrosenko Maria1 aMyles John1 aKaufman James1 aPalevsky Paul1 aPRESERVE Trial Group00aOutcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.  a603-6140 v3783 a<p><b>BACKGROUND: </b>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.</p><p><b>METHODS: </b>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.</p><p><b>RESULTS: </b>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.</p><p><b>CONCLUSIONS: </b>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 .).</p>  a1533-4406