NCT06654895Recruiting
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Bluejay Diagnostics, Inc.
Start Date
11/12/2024
Completion Date
8/30/2026
Summary
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
Eligibility Criteria
Age Range: 22 years to No maximum
Inclusion Criteria:
* 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.
* Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
* Septic shock: sepsis requiring vasopressors and serum lactate levels \>2 mmol/L (18 mg/dL)
* Admitted or intended to be admitted to the ICU
* At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.
Exclusion Criteria:
* Prisoners or imprisonment at time of enrollment
* Prior enrollment into this study
* Informed consent as approved by IRB is unable to be obtained.
Conditions
Sepsis, Septic Shock
Locations
University of Florida College of Medicine
Gainesville, Florida 32610
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Wake Forest School of Medicine
Winston-Salem, North Carolina 27157
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Intermountain Health
Salt Lake City, Utah 84111
United States