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NCT Number: NCT07734480

Comparison of NEWS2 and Machine Learning for Early Sepsis Warning

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sepsis Infections Inflammation Machine Learning News-2 Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational study - no intervention

Other

Observational Study - No Intervention

Primary outcomes

  1. Lead-Time Calculated from NEWS2 KDS Alert and SOFA Score Change

    Time frame: 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

  1. Predictive Performance of Machine Learning Model vs KDS

    Time frame: Within 14 days of hospital admission

Sponsors and collaborators

Lead sponsor

Kocaeli Derince Education and Research Hospital

Other

Registry information

Official study title

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

Acronym: SEW-ML

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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