Outcomes after angiography with sodium bicarbonate and acetylcysteine

PRESERVE Trial Group, Graham Hillis

Research output: Contribution to journalArticle

121 Citations (Scopus)

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
JournalThe New 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

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title = "Outcomes after angiography with sodium bicarbonate and acetylcysteine",
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 .).",
keywords = "Acetylcysteine/therapeutic use, Acute Kidney Injury/chemically induced, Administration, Oral, Aged, Angiography/adverse effects, Contrast Media/adverse effects, Creatinine/blood, Double-Blind Method, Female, Fluid Therapy, Humans, Infusions, Intravenous, Male, Middle Aged, Renal Dialysis, Renal Insufficiency, Chronic/therapy, Risk Factors, Sodium Bicarbonate/therapeutic use, Sodium Chloride/therapeutic use, Treatment Outcome",
author = "{PRESERVE Trial Group} and 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.} and Graham Hillis",
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language = "English",
volume = "378",
pages = "603--614",
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Outcomes after angiography with sodium bicarbonate and acetylcysteine. / PRESERVE Trial Group ; Hillis, Graham.

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

Research output: Contribution to journalArticle

TY - JOUR

T1 - Outcomes after angiography with sodium bicarbonate and acetylcysteine

AU - PRESERVE Trial Group

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.

AU - Hillis, Graham

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 .).

KW - Acetylcysteine/therapeutic use

KW - Acute Kidney Injury/chemically induced

KW - Administration, Oral

KW - Aged

KW - Angiography/adverse effects

KW - Contrast Media/adverse effects

KW - Creatinine/blood

KW - Double-Blind Method

KW - Female

KW - Fluid Therapy

KW - Humans

KW - Infusions, Intravenous

KW - Male

KW - Middle Aged

KW - Renal Dialysis

KW - Renal Insufficiency, Chronic/therapy

KW - Risk Factors

KW - Sodium Bicarbonate/therapeutic use

KW - Sodium Chloride/therapeutic use

KW - Treatment Outcome

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U2 - 10.1056/NEJMoa1710933

DO - 10.1056/NEJMoa1710933

M3 - Article

VL - 378

SP - 603

EP - 614

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 7

ER -