Actively Recruiting

Age: 22Years +
All Genders
NCT06654895

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

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here