Abstract
BackgroundNeutrophil gelatinase-associated lipocalin (NGAL) is released from kidney tubular cells under stress as well as from neutrophils during inflammation. It has been suggested as a biomarker for acute kidney injury (AKI) in critically ill patients with sepsis. To evaluate clinical usefulness of urine NGAL (uNGAL), we post-hoc applied recently introduced statistical methods to a sub-cohort of septic patients from the prospective observational Finnish Acute Kidney Injury (FINNAKI) study. Accordingly, in 484 adult intensive care unit patients with sepsis by Sepsis-3 criteria, we calculated areas under the receiver operating characteristic curves (AUCs) for the first available uNGAL to assess discrimination for four outcomes: AKI defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria, severe (KDIGO 2–3) AKI, and renal replacement therapy (RRT) during the first 3 days of intensive care, and mortality at day 90. We constructed clinical prediction models for the outcomes and used risk assessment plots and decision curve analysis with predefined threshold probabilities to test whether adding uNGAL to the models improved reclassification or decision making in clinical practice.ResultsIncidences of AKI, severe AKI, RRT, and mortality were 44.8% (217/484), 27.7% (134/484), 9.5% (46/484), and 28.1% (136/484). Corresponding AUCs for uNGAL were 0.690, 0.728, 0.769, and 0.600. Adding uNGAL to the clinical prediction models improved discrimination of AKI, severe AKI, and RRT. However, the net benefits for the new models were only 1.4% (severe AKI and RRT) to 2.5% (AKI), and the number of patients needed to be tested per one extra true-positive varied from 40 (AKI) to 74 (RRT) at the predefined threshold probabilities.ConclusionsThe results of the recommended new statistical methods do not support the use of uNGAL in critically ill septic patients to predict AKI or clinical outcomes.
Highlights
Neutrophil gelatinase-associated lipocalin (NGAL) is released from kidney tubular cells under stress as well as from neutrophils during inflammation
We extended our analyses to evaluate the usefulness of urine NGAL (uNGAL) in predicting acute kidney injury (AKI), renal replacement therapy (RRT), and 90-day mortality in septic patients using more sophisticated statistical methods: risk assessment plot (RAP) [14] and decision curve analysis (DCA) [10]
We present the data as medians with interquartile ranges (IQRs) or absolute numbers
Summary
Neutrophil gelatinase-associated lipocalin (NGAL) is released from kidney tubular cells under stress as well as from neutrophils during inflammation It has been suggested as a biomarker for acute kidney injury (AKI) in critically ill patients with sepsis. To evaluate clinical usefulness of urine NGAL (uNGAL), we post-hoc applied recently introduced statistical methods to a sub-cohort of septic patients from the prospective observational Finnish Acute Kidney Injury (FINNAKI) study. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied extensively as a biomarker for detection and evolution of acute kidney injury (AKI) as well as outcome [1, 2]. In a recent meta-analysis, urine NGAL (uNGAL) predicted septic AKI with an area under the receiver operating characteristic curve (AUC) of 0.90 [8], but the individual studies were rather small, the sample sizes varying between 45 and 168. There is obvious need for better tools than urine output and serum creatinine for early detection and classification of AKI, the existing data on any kidney injury biomarker for AKI diagnosis, staging, prognosis, or treatment are inadequate [12]
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