Outcomes after angiography with sodium bicarbonate and acetylcysteine

S. D. Weisbord, M. Gallagher, H. Jneid, S. Garcia, A. Cass, S. S. Thwin, T. A. Conner, G. M. Chertow, D. L. Bhatt, K. Shunk, C. R. Parikh, E. O. McFalls, M. Brophy, R. Ferguson, H. Wu, M. Androsenko, J. Myles, J. Kaufman, P. M. Palevsky

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    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.)

    Original languageEnglish
    Pages (from-to)603-614
    Number of pages12
    JournalNew England Journal of Medicine
    Volume378
    Issue number7
    DOIs
    Publication statusPublished - 15 Feb 2018

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    Sodium Bicarbonate
    Acetylcysteine
    Angiography
    Acute Kidney Injury
    Sodium Chloride
    Placebos
    Kidney
    Dialysis
    Odds Ratio
    Confidence Intervals
    United States Department of Veterans Affairs
    Intention to Treat Analysis
    Biomedical Research
    Creatinine
    Health
    Serum
    Research

    Cite this

    Weisbord, S. D., Gallagher, M., Jneid, H., Garcia, S., Cass, A., Thwin, S. S., ... Palevsky, P. M. (2018). Outcomes after angiography with sodium bicarbonate and acetylcysteine. New England Journal of Medicine, 378(7), 603-614. https://doi.org/10.1056/NEJMoa1710933
    Weisbord, S. D. ; Gallagher, M. ; Jneid, H. ; Garcia, S. ; Cass, A. ; Thwin, S. S. ; Conner, T. A. ; Chertow, G. M. ; Bhatt, D. L. ; Shunk, K. ; Parikh, C. R. ; McFalls, E. O. ; Brophy, M. ; Ferguson, R. ; Wu, H. ; Androsenko, M. ; Myles, J. ; Kaufman, J. ; Palevsky, P. M. / Outcomes after angiography with sodium bicarbonate and acetylcysteine. In: New England Journal of Medicine. 2018 ; Vol. 378, No. 7. pp. 603-614.
    @article{3dd3849673224615904193870c2a9f8b,
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    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.)",
    author = "Weisbord, {S. D.} and M. Gallagher and H. Jneid and S. Garcia and A. Cass and Thwin, {S. S.} and Conner, {T. A.} and Chertow, {G. M.} and Bhatt, {D. L.} and K. Shunk and Parikh, {C. R.} and McFalls, {E. O.} and M. Brophy and R. Ferguson and H. Wu and M. Androsenko and J. Myles and J. Kaufman and Palevsky, {P. M.}",
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    Weisbord, SD, Gallagher, M, Jneid, H, Garcia, S, Cass, A, Thwin, SS, Conner, TA, Chertow, GM, Bhatt, DL, Shunk, K, Parikh, CR, McFalls, EO, Brophy, M, Ferguson, R, Wu, H, Androsenko, M, Myles, J, Kaufman, J & Palevsky, PM 2018, 'Outcomes after angiography with sodium bicarbonate and acetylcysteine', New England Journal of Medicine, vol. 378, no. 7, pp. 603-614. https://doi.org/10.1056/NEJMoa1710933

    Outcomes after angiography with sodium bicarbonate and acetylcysteine. / Weisbord, S. D.; Gallagher, M.; Jneid, H.; Garcia, S.; Cass, A.; Thwin, S. S.; Conner, T. A.; Chertow, G. M.; Bhatt, D. L.; Shunk, K.; Parikh, C. R.; McFalls, E. O.; Brophy, M.; Ferguson, R.; Wu, H.; Androsenko, M.; Myles, J.; Kaufman, J.; Palevsky, P. M.

    In: New England Journal of Medicine, Vol. 378, No. 7, 15.02.2018, p. 603-614.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Outcomes after angiography with sodium bicarbonate and acetylcysteine

    AU - Weisbord, S. D.

    AU - Gallagher, M.

    AU - Jneid, H.

    AU - Garcia, S.

    AU - Cass, A.

    AU - Thwin, S. S.

    AU - Conner, T. A.

    AU - Chertow, G. M.

    AU - Bhatt, D. L.

    AU - Shunk, K.

    AU - Parikh, C. R.

    AU - McFalls, E. O.

    AU - Brophy, M.

    AU - Ferguson, R.

    AU - Wu, H.

    AU - Androsenko, M.

    AU - Myles, J.

    AU - Kaufman, J.

    AU - Palevsky, P. M.

    PY - 2018/2/15

    Y1 - 2018/2/15

    N2 - 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.)

    AB - 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.)

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    DO - 10.1056/NEJMoa1710933

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    JO - New England Journal of Medicine

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