NCT07126106 Prospective Validation of GRADY: A Machine Learning Model for Early Sepsis and Bacteremia Detection in ICU Patients
| NCT ID | NCT07126106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
| Condition | Bacteremia |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2025-02-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Patients younger than 18 years * ICU stay shorter than 48 hours * Patients without blood cultures
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07126106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07126106 currently recruiting?
Yes, NCT07126106 is actively recruiting participants. Contact the research team at okanderin@gmail.com for enrollment information.
Where is the NCT07126106 trial being conducted?
This trial is being conducted at Seyrantepe, Turkey (Türkiye).
Who is sponsoring the NCT07126106 clinical trial?
NCT07126106 is sponsored by Sisli Hamidiye Etfal Training and Research Hospital. The trial plans to enroll 55 participants.