Prospective Validation of GRADY: A Machine Learning Model for Early Sepsis and Bacteremia Detection in ICU Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSisli Hamidiye Etfal Training and Research Hospital

About this trial

This study aims to prospectively validate the GRADY prediction models, which use machine learning algorithms to estimate the risk of gram-negative bacteremia and sepsis in intensive care unit (ICU) patients based on routinely collected vital signs and laboratory data. Sepsis, a life-threatening condition associated with high ICU mortality, requires early diagnosis and treatment-yet current diagnostic methods relying on blood cultures are time-consuming. Existing scoring systems such as SOFA, SIRS, and NEWS2 often lack sufficient sensitivity and specificity in early sepsis detection. Unlike traditional tools, the GRADY models seek to provide earlier and more accurate risk stratification. This study will compare the clinical performance of GRADY models against standard scoring systems and explore their integration as early warning tools to support rapid intervention and improve outcomes in critical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older

ICU stay of 48 hours or longer

Patients from whom blood cultures were obtained during routine monitoring

Signed informed consent form

Disqualifiers

Patients younger than 18 years

ICU stay shorter than 48 hours

Patients without blood cultures

Trial population

Patients over the age of 18 who are suspected of having bacteremia while being treated in intensive care will be included in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Gram(-) negative bacteremia

Gram (-) bacteria growth in blood culture

Time frame
1-28 days

Secondary outcomes

1

SOFA

The Sequential Organ Failure Assessment (SOFA) score is a clinical tool that evaluates the extent of a patient's organ dysfunction based on six parameters - respiratory function (PaO₂/FiO₂), coagulation (platelet count), liver function (bilirubin level), cardiovascular status (mean arterial pressure or vasopressor use), central nervous system function (Glasgow Coma Scale), and renal function (creatinine level or urine output) - and it will be assessed at the time of patient admission.

Time frame
it will be assessed at the time of patient admission.
2

SIRS

The Systemic Inflammatory Response Syndrome (SIRS) criteria are used to identify a generalized inflammatory state based on four parameters - body temperature, heart rate, respiratory rate or PaCO₂, and white blood cell count

Time frame
they will be assessed at the time of patient admission
3

NEWS-2

The National Early Warning Score 2 (NEWS-2) is a clinical scoring system used to assess the severity of a patient's acute illness based on six parameters - respiratory rate, oxygen saturation, systolic blood pressure, heart rate, level of consciousness or new confusion, and temperature

Time frame
it will be assessed at the time of patient admission.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sisli etfal research and training hospitalRecruiting34371, Seyrantepe, IstanbulTurkey (Türkiye)

Sponsors and contacts

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