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NCT07734480

Comparison of NEWS2 and Machine Learning for Early Sepsis Warning

Sponsor: Kocaeli Derince Education and Research Hospital

View on ClinicalTrials.gov

Summary

This prospective observational study aims to objectively measure the lead-time (the time from the first KDS alert to sepsis diagnosis) of the NEWS2-based clinical decision support system (KDS) and compare its early warning performance with a machine learning model trained on 2000 patients and externally validated. The study seeks to answer the following main questions: How early does the NEWS2-based KDS provide an alert before sepsis diagnosis? Does a machine learning model, developed using logistic regression and externally validated in a prospective cohort, offer superior specificity and comparable sensitivity to KDS? Participants who are already receiving routine clinical care at Kocaeli City Hospital will have their vital signs and laboratory data monitored as part of standard practice. NEWS2 scores will be calculated automatically and the time of the first alert (T0) will be recorded. Sepsis diagnosis will be confirmed by an increase in SOFA score ≥ 2 (T1), evaluated by two independent and blinded physicians. Lead-time will be calculated as the difference between T1 (hours×60) and T0 (minutes). The machine learning model will be tested prospectively on this cohort, and its performance will be compared with KDS using sensitivity, specificity, F1 score, ROC-AUC, and accuracy.

Official title: Comparison of NEWS2 and a Machine Learning Model for Early Sepsis Warning: A Prospective Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-07-22

Completion Date

2026-08-13

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

OTHER

Observational Study - No Intervention

Observational Study - No Intervention

Locations (1)

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)