November 21, 2017
PRESERVE Trial Indicates No Benefit for Sodium Bicarbonate or Acetylcysteine for Patients With Impaired Kidney Function Undergoing Angiography
November 21, 2017—New data from the PRESERVE clinical trial suggests intravenous sodium bicarbonate has no clinical benefit over the use of 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, among high-risk patients for renal complications undergoing angiography. The data were published online in the New England Journal of Medicine (NEJM) by Steven D. Weisbord, MD, et al.
According to the investigators, intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury but also associated with adverse outcomes after angiography without definitive evidence of their efficacy.
As summarized in NEJM, researchers used a 2-by-2 factorial design to randomly assign 5,177 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. A total of 4,993 patients were included in the modified intention-to-treat analysis.
The primary endpoint 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 endpoint.
The primary endpoint occurred in 110 of 2,511 (4.4%) patients in the sodium bicarbonate group as compared with 116 of 2,482 (4.7%) patients in the sodium chloride group (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.72–1.22; P = .62) and in 114 of 2,495 (4.6%) patients in the acetylcysteine group as compared with 112 of 2,498 (4.5%) patients in the placebo group (OR, 1.02; 95% CI, 0.78–1.33; P = .88).
There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary endpoint (P = .33). In regard to the secondary endpoint, no significant between-group differences were observed in the rates of contrast-associated acute kidney injury.
The trial was stopped by the sponsor, the United States Department of Veterans Affairs Office of Research, after a prespecified interim analysis, advised the investigators in NEJM.