MONDAY, Nov. 13, 2017 (HealthDay News) — For patients at high risk for renal complications who are scheduled for angiography, there is no benefit with intravenous sodium bicarbonate over sodium chloride or with oral acetylcysteine over placebo, according to a study published online Nov. 12 in the New England Journal of Medicine to coincide with the American Heart Association’s Scientific Sessions, being held Nov. 11 to 15 in Anaheim, California.
Steven D. Weisbord, M.D., from the Veterans Affairs Pittsburgh Healthcare System and the University of Pittsburgh School of Medicine, and colleagues randomized 5,177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous sodium bicarbonate or sodium chloride and five days of oral acetylcysteine or placebo. The trial was stopped after a prespecified interim analysis, and 4,993 patients were included in the modified intention-to-treat analysis.
The researchers found that there was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P = 0.33), which was a composite of death, need for dialysis, or a persistent increase of at least 50 percent in the serum creatinine level from baseline to 90 days. The primary end point occurred in 4.4 and 4.7 percent of patients in the sodium bicarbonate and sodium chloride groups (odds ratio, 0.93; 95 percent confidence interval, 0.72 to 1.22; P = 0.62) and in 4.6 and 4.5 percent of patients in the acetylcysteine and placebo groups (odds ratio, 1.02; 95 percent confidence interval, 0.78 to 1.33; P = 0.88).
“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,” the authors write.
Several authors disclosed financial ties to pharmaceutical and medical device companies.
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