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NCT07874698
Clinical Outcomes Using Molecular Prediction in Acute Suspected Sepsis and Infection
Conditions: Sepsis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 400
Sponsor: Unity Health Toronto
Summary
Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for signs of infection, which can take up to 3 days. There aren't currently any tests that allow doctors to predict patient outcome, hospital course, or severity of illness. Our team has identified a set of genes that when combined can predict the likelihood of clinical deterioration; this set of genes is called SEPSET. In this study the investigators will evaluate the predictive capability of SEPSET along with clinical and laboratory measures in patients with suspected infection.
Eligibility Criteria
Inclusion Criteria:
* Adult patients 18 years of age or older
* Suspicion of infection - as defined by:
* Physician documentation of suspected infection. OR
* Initiation of a sepsis-related diagnostic or treatment pathway within 24 hours of presentation
OR
* EPIC - ALERT System Identifies patient as risk for Sepsis AND
* Lactate ≥3 OR pH ≤7.35 and at least 2 of the following SIRS Criteria that cannot be explained by another diagnosis:
* Temperature \>38.3°C or \110 bpm
* Respiratory Rate \>25 or PaCO2 \12,000 mm3, \
Source: ClinicalTrials.gov (NCT07874698). StuddyBuddy aggregates publicly available trial information.