RecruitingNCT07126106

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

Prospective Validation of the GRADY Bacteremia/Sepsis Prediction Model in Intensive Care Unit Patients: Clinical Performance and Feasibility as an Early Warning System


Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Enrollment

55 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria3

  • Patients younger than 18 years
  • ICU stay shorter than 48 hours
  • Patients without blood cultures

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Locations(1)

Sisli etfal research and training hospital

Seyrantepe, Istanbul, Turkey (Türkiye)

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NCT07126106


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