Comparison of NEWS2 and Machine Learning for Early Sepsis Warning

NCT07734480 — Active not recruiting, 100 participants, Kocaeli Derince Education and Research Hospital

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

Registry	NCT07734480, acronym SEW-ML
Status	Active not recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Kocaeli Derince Education and Research Hospital (Other)
Conditions	Sepsis, News-2, Machine Learning
Interventions	Observational Study - No Intervention (Other)
Dates	start 2026-07-22, primary completion 2026-08-11, completion 2026-08-13 (estimated), first posted 2026-07-29, last updated 2026-08-13
Locations	1 site in Turkey (Türkiye)

-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.

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+Detailed description

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Early recognition and treatment are critical for improving outcomes. The National Early Warning Score 2 (NEWS2) is widely used as an early warning system, but its lead-time (the time from alert to diagnosis) has not been objectively measured in prospective studies. This study aims to fill this gap by prospectively evaluating the lead-time of NEWS2-based KDS and comparing its performance with a machine learning model. The machine learning model was developed using 2000 patients from the PhysioNet Sepsis Prediction Challenge 2019 database and externally validated on a prospective cohort of 100 patients from Kocaeli City Hospital. The study will provide evidence on the comparative utility of traditional warning systems and machine learning approaches for early sepsis detection.

+Arms and interventions

Observational Study - No Intervention (Other): Observational Study - No Intervention

+Outcome measures

Primary outcomes

Lead-Time Calculated from NEWS2 KDS Alert and SOFA Score Change [From hospital admission to sepsis diagnosis, death, or discharge, whichever occurs first, assessed up to 14 days]: Lead-time is defined as the time from the first KDS alert (NEWS2 ≥ 5) to the diagnosis of sepsis, confirmed by an increase in SOFA score ≥ 2 points. It is calculated using the formula: Lead-Time (minutes) = \[T1 (hours × 60)\] - T0 (minutes), where T0 is the time of the first NEWS2 measurement and T1 is the time of first SOFA increase ≥ 2.

Secondary outcomes

Predictive Performance of Machine Learning Model vs KDS [Within 14 days of hospital admission]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients aged 18 years and older
* Admitted to Kocaeli City Hospital Anesthesiology and Reanimation Clinic
* Suspected infection at the time of hospital admission
* Complete vital signs recorded
* Informed consent obtained from the patient or legal representative

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant patients
* Patients with chronic kidney disease requiring dialysis
* Patients with a history of organ transplantation
* Patients with incomplete data

+Locations (1)

Facility	City	Country	Status
Kocaeli City Hospital	Kocaeli, Izmit	Turkey (Türkiye)