RecruitingNCT07734480

SEPSIS EARLY WARNING: NEWS2 VS MACHINE LEARNING

COMPARISON OF NEWS2 AND A MACHINE LEARNING MODEL FOR EARLY SEPSIS WARNING: A PROSPECTIVE OBSERVATIONAL STUDY


Sponsor

Kocaeli Derince Education and Research Hospital

Enrollment

100 participants

Start Date

Jul 22, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Observational Study - No Intervention for people with machine learning, news-2, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservational Study - No Intervention

Observational Study - No Intervention


Locations(1)

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

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NCT07734480


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