Prevention of contrast-induced AKI

a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial

Steven Weisbord, Martin Gallagher, J Kaufman, Alan Cass, Chirag Parikh, Glenn Chertow, Kendrick Shunk, Peter McCullough, Michael Fine, Maria Mor, Robert Lew, Grant Huang, Todd Conner, Mary Brophy, J Lee, Susan Soliva, Paul Palevsky

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. 
    Original languageEnglish
    Pages (from-to)1618-1631
    Number of pages14
    JournalClinical Journal of the American Society of Nephrology
    Volume8
    Issue number9
    DOIs
    Publication statusPublished - 6 Sep 2013

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    Acetylcysteine
    Angiography
    Sodium Bicarbonate
    Sodium Chloride
    Kidney
    Multicenter Studies
    Meta-Analysis
    Creatinine
    Biomarkers
    Placebos
    Clinical Trials
    Serum
    Population

    Cite this

    Weisbord, Steven ; Gallagher, Martin ; Kaufman, J ; Cass, Alan ; Parikh, Chirag ; Chertow, Glenn ; Shunk, Kendrick ; McCullough, Peter ; Fine, Michael ; Mor, Maria ; Lew, Robert ; Huang, Grant ; Conner, Todd ; Brophy, Mary ; Lee, J ; Soliva, Susan ; Palevsky, Paul. / Prevention of contrast-induced AKI : a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial. In: Clinical Journal of the American Society of Nephrology. 2013 ; Vol. 8, No. 9. pp. 1618-1631.
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    abstract = "Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. ",
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    Weisbord, S, Gallagher, M, Kaufman, J, Cass, A, Parikh, C, Chertow, G, Shunk, K, McCullough, P, Fine, M, Mor, M, Lew, R, Huang, G, Conner, T, Brophy, M, Lee, J, Soliva, S & Palevsky, P 2013, 'Prevention of contrast-induced AKI: a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial', Clinical Journal of the American Society of Nephrology, vol. 8, no. 9, pp. 1618-1631. https://doi.org/10.2215/CJN.11161012

    Prevention of contrast-induced AKI : a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial. / Weisbord, Steven; Gallagher, Martin; Kaufman, J; Cass, Alan; Parikh, Chirag; Chertow, Glenn; Shunk, Kendrick; McCullough, Peter; Fine, Michael; Mor, Maria; Lew, Robert; Huang, Grant; Conner, Todd; Brophy, Mary; Lee, J; Soliva, Susan; Palevsky, Paul.

    In: Clinical Journal of the American Society of Nephrology, Vol. 8, No. 9, 06.09.2013, p. 1618-1631.

    Research output: Contribution to journalArticleResearchpeer-review

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    T1 - Prevention of contrast-induced AKI

    T2 - a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial

    AU - Weisbord, Steven

    AU - Gallagher, Martin

    AU - Kaufman, J

    AU - Cass, Alan

    AU - Parikh, Chirag

    AU - Chertow, Glenn

    AU - Shunk, Kendrick

    AU - McCullough, Peter

    AU - Fine, Michael

    AU - Mor, Maria

    AU - Lew, Robert

    AU - Huang, Grant

    AU - Conner, Todd

    AU - Brophy, Mary

    AU - Lee, J

    AU - Soliva, Susan

    AU - Palevsky, Paul

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    N2 - Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. 

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