Status:
COMPLETED
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study
Lead Sponsor:
Bluejay Diagnostics, Inc.
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
22+ years
Brief Summary
The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are int...
Eligibility Criteria
Inclusion
- Adult patients (≥22 years of age)
- Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
- Admitted or intended to be admitted to the ICU
- At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock.
Exclusion
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT06181604
Start Date
January 12 2024
End Date
July 12 2024
Last Update
August 3 2025
Active Locations (7)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Washington University of St. Louis
St Louis, Missouri, United States, 63110
3
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
4
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157