An observational study in Sepsis, News-2 and Machine Learning, sponsored by Kocaeli Derince Education and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Kocaeli Derince Education and Research Hospital · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Kocaeli Derince Education and Research Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) with suspected infection admitted to the Anesthesiology and Reanimation Clinic of Kocaeli City Hospital. Patients are enrolled prospectively if they meet the inclusion criteria and provide informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational Study - No Intervention
Lead-Time Calculated from NEWS2 KDS Alert and SOFA Score Change
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.
Time frame: From hospital admission to sepsis diagnosis, death, or discharge, whichever occurs first, assessed up to 14 days
Predictive Performance of Machine Learning Model vs KDS
Time frame: Within 14 days of hospital admission
Plan to share: No — Individual participant data will not be shared due to institutional ethics committee restrictions and the absence of specific consent from participants for data sharing. Only anonymized summary data will be reported in the publication.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kocaeli Derince Education and Research Hospital