Actively Recruiting
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Led by Bluejay Diagnostics, Inc. · Updated on 2026-02-03
700
Participants Needed
5
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥22 years of age)
- Diagnosed with sepsis or septic shock based on the Third International Consensus Definitions (Sepsis-3 criteria)
- Sepsis defined as suspected or documented infection and organ dysfunction with SOFA score ≥2
- Septic shock defined as 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 available or anticipated to be drawn within 24 hours after earliest sepsis or septic shock diagnosis
You will not qualify if you...
- Prisoners or currently imprisoned at time of enrollment
- Previously enrolled in this study
- Unable to obtain informed consent as approved by the Institutional Review Board (IRB)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
Intermountain Health
Salt Lake City, Utah, United States, 84111
Actively Recruiting
Research Team
C
Clinical Affairs
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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