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      Biomarker-Guided Risk Assessment for Acute Kidney Injury: Time for Clinical Implementation?

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          Abstract

          Acute kidney injury (AKI) is a common and serious complication in hospitalized patients, which continues to pose a clinical challenge for treating physicians. The most recent Kidney Disease Improving Global Outcomes practice guidelines for AKI have restated the importance of earliest possible detection of AKI and adjusting treatment accordingly. Since the emergence of initial studies examining the use of neutrophil gelatinase-associated lipocalin (NGAL) and cycle arrest biomarkers, tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor-binding protein (IGFBP7), for early diagnosis of AKI, a vast number of studies have investigated the accuracy and additional clinical benefits of these biomarkers. As proposed by the Acute Dialysis Quality Initiative, new AKI diagnostic criteria should equally utilize glomerular function and tubular injury markers for AKI diagnosis. In addition to refining our capabilities in kidney risk prediction with kidney injury biomarkers, structural disorder phenotypes referred to as “preclinical-” and “subclinical AKI” have been described and are increasingly recognized. Additionally, positive biomarker test findings were found to provide prognostic information regardless of an acute decline in renal function (positive serum creatinine criteria). We summarize and discuss the recent findings focusing on two of the most promising and clinically available kidney injury biomarkers, NGAL and cell cycle arrest markers, in the context of AKI phenotypes. Finally, we draw conclusions regarding the clinical implications for kidney risk prediction.

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          Acute kidney injury, mortality, length of stay, and costs in hospitalized patients.

          The marginal effects of acute kidney injury on in-hospital mortality, length of stay (LOS), and costs have not been well described. A consecutive sample of 19,982 adults who were admitted to an urban academic medical center, including 9210 who had two or more serum creatinine (SCr) determinations, was evaluated. The presence and degree of acute kidney injury were assessed using absolute and relative increases from baseline to peak SCr concentration during hospitalization. Large increases in SCr concentration were relatively rare (e.g., >or=2.0 mg/dl in 105 [1%] patients), whereas more modest increases in SCr were common (e.g., >or=0.5 mg/dl in 1237 [13%] patients). Modest changes in SCr were significantly associated with mortality, LOS, and costs, even after adjustment for age, gender, admission International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis, severity of illness (diagnosis-related group weight), and chronic kidney disease. For example, an increase in SCr >or=0.5 mg/dl was associated with a 6.5-fold (95% confidence interval 5.0 to 8.5) increase in the odds of death, a 3.5-d increase in LOS, and nearly 7500 dollars in excess hospital costs. Acute kidney injury is associated with significantly increased mortality, LOS, and costs across a broad spectrum of conditions. Moreover, outcomes are related directly to the severity of acute kidney injury, whether characterized by nominal or percentage changes in serum creatinine.
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            Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond.

            Identification of key factors associated with the risk of developing cardiovascular disease and quantification of this risk using multivariable prediction algorithms are among the major advances made in preventive cardiology and cardiovascular epidemiology in the 20th century. The ongoing discovery of new risk markers by scientists presents opportunities and challenges for statisticians and clinicians to evaluate these biomarkers and to develop new risk formulations that incorporate them. One of the key questions is how best to assess and quantify the improvement in risk prediction offered by these new models. Demonstration of a statistically significant association of a new biomarker with cardiovascular risk is not enough. Some researchers have advanced that the improvement in the area under the receiver-operating-characteristic curve (AUC) should be the main criterion, whereas others argue that better measures of performance of prediction models are needed. In this paper, we address this question by introducing two new measures, one based on integrated sensitivity and specificity and the other on reclassification tables. These new measures offer incremental information over the AUC. We discuss the properties of these new measures and contrast them with the AUC. We also develop simple asymptotic tests of significance. We illustrate the use of these measures with an example from the Framingham Heart Study. We propose that scientists consider these types of measures in addition to the AUC when assessing the performance of newer biomarkers.
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              Acute kidney injury

              Acute kidney injury (AKI) is defined by a rapid increase in serum creatinine, decrease in urine output, or both. AKI occurs in approximately 10-15% of patients admitted to hospital, while its incidence in intensive care has been reported in more than 50% of patients. Kidney dysfunction or damage can occur over a longer period or follow AKI in a continuum with acute and chronic kidney disease. Biomarkers of kidney injury or stress are new tools for risk assessment and could possibly guide therapy. AKI is not a single disease but rather a loose collection of syndromes as diverse as sepsis, cardiorenal syndrome, and urinary tract obstruction. The approach to a patient with AKI depends on the clinical context and can also vary by resource availability. Although the effectiveness of several widely applied treatments is still controversial, evidence for several interventions, especially when used together, has increased over the past decade.
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                Author and article information

                Journal
                Ann Lab Med
                Ann Lab Med
                Annals of Laboratory Medicine
                Korean Society for Laboratory Medicine
                2234-3806
                2234-3814
                January 2021
                01 January 2021
                : 41
                : 1
                : 1-15
                Affiliations
                [1 ]Medical Faculty, University Clinic for Cardiology and Angiology, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
                [2 ]Diaverum Renal Services, MVZ Potsdam, Potsdam, Germany
                [3 ]Medical Faculty, Otto-von-Guericke University Magdeburg, Magdeburg, Germany
                [4 ]Department of Nephrology and Endocrinology, Klinikum Ernst von Bergmann, Potsdam, Germany
                [5 ]Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany
                [6 ]Department of Cardiology, Immanuel Diakonie Bernau, Heart Center Brandenburg, Brandenburg Medical School Theodor Fontane (MHB), Germany
                [7 ]Institute of Social Medicine and Health Systems Research, Otto-von-Guericke University Magdeburg, Magdeburg, Germany
                [8 ]Faculty of Health Sciences Brandenburg, Potsdam, Germany
                Author notes
                Corresponding author: Christian Albert, M.D. Medical Faculty, University Clinic for Cardiology and Angiology, Otto-von-Guericke University, Leipziger Straße 44, 39120 Magdeburg, Germany and Diaverum Renal Services, Germany Diaverum MVZ Am Neuen Garten, Am Neuen Garten 11, 14469 Potsdam, Germany, Tel: +49-331-280690, Fax: +49-331-2806932, E-mail: Christian.Albert@ 123456Diaverum.com
                Author information
                https://orcid.org/0000-0002-6956-9962
                https://orcid.org/0000-0001-8212-7416
                https://orcid.org/0000-0002-5611-1506
                https://orcid.org/0000-0001-5339-2472
                https://orcid.org/0000-0003-3888-6532
                https://orcid.org/0000-0001-6881-2249
                Article
                alm-2021-41-1-1
                10.3343/alm.2021.41.1.1
                7443517
                32829575
                cd28cba9-ee39-41d3-a658-619727b2a50a
                Copyright © Korean Society for Laboratory Medicine

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 February 2020
                : 23 May 2020
                : 02 August 2020
                Categories
                Review Article
                Clinical Chemistry

                Clinical chemistry
                acute kidney injury,aki phenotypes,neutrophil gelatinase-associated lipocalin,subclinical aki,preclinical aki,kidney biomarker,serum creatinine,kidney risk prediction,cell cycle arrest biomarker

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