Early prediction of sepsis in intensive care patients using the machine learning algorithm NAVOY® Sepsis, a prospective randomized clinical validation study.

PURPOSE: To prospectively validate, in an ICU setting, the prognostic accuracy of the sepsis prediction algorithm NAVOY® Sepsis which uses 4 h of input for routinely collected vital parameters, blood gas values, and lab values. MATERIALS AND METHODS: Patients 18 years or older admitted to the ICU at Skåne University Hospital Malmö from December 2020 to September 2021 were recruited in the study. A total of 304 patients were randomized into one of two groups: Algorithm group with active sepsis alerts, or Standard of care. NAVOY® Sepsis made silent predictions in the Standard of care group, in order to evaluate its performance without disturbing the outcome. The study was blinded, i.e., study personnel did not know to which group patients were randomized. The healthcare provider followed standard practices in assessing possible development of sepsis and intervening accordingly. The patients were followed-up in the study until ICU discharge. RESULTS: NAVOY® Sepsis could predict the development of sepsis, according to the Sepsis-3 criteria, three hours before sepsis onset with high performance: accuracy 0.79; sensitivity 0.80; and specificity 0.78. CONCLUSIONS: The accuracy, sensitivity, and specificity were all high, validating the prognostic accuracy of NAVOY® Sepsis in an ICU setting, including Covid-19 patients.

A Machine Learning Algorithm Predicting Acute Kidney Injury in Intensive Care Unit Patients (NAVOY Acute Kidney Injury): Proof-of-Concept Study.

BACKGROUND: Acute kidney injury (AKI) represents a significant global health challenge, leading to increased patient distress and financial health care burdens. The development of AKI in intensive care unit (ICU) settings is linked to prolonged ICU stays, a heightened risk of long-term renal dysfunction, and elevated short- and long-term mortality rates. The current diagnostic approach for AKI is based on late indicators, such as elevated serum creatinine and decreased urine output, which can only detect AKI after renal injury has transpired. There are no treatments to reverse or restore renal function once AKI has developed, other than supportive care. Early prediction of AKI enables proactive management and may improve patient outcomes. OBJECTIVE: The primary aim was to develop a machine learning algorithm, NAVOY Acute Kidney Injury, capable of predicting the onset of AKI in ICU patients using data routinely collected in ICU electronic health records. The ultimate goal was to create a clinical decision support tool that empowers ICU clinicians to proactively manage AKI and, consequently, enhance patient outcomes. METHODS: We developed the NAVOY Acute Kidney Injury algorithm using a hybrid ensemble model, which combines the strengths of both a Random Forest (Leo Breiman and Adele Cutler) and an XGBoost model (Tianqi Chen). To ensure the accuracy of predictions, the algorithm used 22 clinical variables for hourly predictions of AKI as defined by the Kidney Disease: Improving Global Outcomes guidelines. Data for algorithm development were sourced from the Massachusetts Institute of Technology Lab for Computational Physiology Medical Information Mart for Intensive Care IV clinical database, focusing on ICU patients aged 18 years or older. RESULTS: The developed algorithm, NAVOY Acute Kidney Injury, uses 4 hours of input and can, with high accuracy, predict patients with a high risk of developing AKI 12 hours before onset. The prediction performance compares well with previously published prediction algorithms designed to predict AKI onset in accordance with Kidney Disease: Improving Global Outcomes diagnosis criteria, with an impressive area under the receiver operating characteristics curve (AUROC) of 0.91 and an area under the precision-recall curve (AUPRC) of 0.75. The algorithm's predictive performance was externally validated on an independent hold-out test data set, confirming its ability to predict AKI with exceptional accuracy. CONCLUSIONS: NAVOY Acute Kidney Injury is an important development in the field of critical care medicine. It offers the ability to predict the onset of AKI with high accuracy using only 4 hours of data routinely collected in ICU electronic health records. This early detection capability has the potential to strengthen patient monitoring and management, ultimately leading to improved patient outcomes. Furthermore, NAVOY Acute Kidney Injury has been granted Conformite Europeenne (CE)-marking, marking a significant milestone as the first CE-marked AKI prediction algorithm for commercial use in European ICUs.

A Machine Learning Sepsis Prediction Algorithm for Intended Intensive Care Unit Use (NAVOY Sepsis): Proof-of-Concept Study.

BACKGROUND: Despite decades of research, sepsis remains a leading cause of mortality and morbidity in intensive care units worldwide. The key to effective management and patient outcome is early detection, for which no prospectively validated machine learning prediction algorithm is currently available for clinical use in Europe. OBJECTIVE: We aimed to develop a high-performance machine learning sepsis prediction algorithm based on routinely collected intensive care unit data, designed to be implemented in European intensive care units. METHODS: The machine learning algorithm was developed using convolutional neural networks, based on Massachusetts Institute of Technology Lab for Computational Physiology MIMIC-III clinical data from intensive care unit patients aged 18 years or older. The model uses 20 variables to produce hourly predictions of onset of sepsis, defined by international Sepsis-3 criteria. Predictive performance was externally validated using hold-out test data. RESULTS: The algorithm-NAVOY Sepsis-uses 4 hours of input and can identify patients with high risk of developing sepsis, with high performance (area under the receiver operating characteristics curve 0.90; area under the precision-recall curve 0.62) for predictions up to 3 hours before sepsis onset. CONCLUSIONS: The prediction performance of NAVOY Sepsis was superior to that of existing sepsis early warning scoring systems and comparable with those of other prediction algorithms designed to predict sepsis onset. The algorithm has excellent predictive properties and uses variables that are routinely collected in intensive care units.