Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Recruiting now
Conditions studied: Sepsis, Septic Shock
In brief
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.
Key facts
- Study ID
- NCT06654895
- Run by
- Bluejay Diagnostics, Inc.
- People needed
- 700
- Starts
- 2024-11-12
- Expected to finish
- 2026-08-30
- Last updated by the study team
- 2026-02-03
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
Where it is running
- University of Florida College of Medicine — Gainesville, Florida, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Intermountain Health — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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