Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Completed

Conditions studied: Sepsis, Septic Shock

In brief

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 intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

Key facts

Study ID

NCT06181604

Run by

Bluejay Diagnostics, Inc.

People needed

143

Starts

2024-01-12

Expected to finish

2024-07-12

Last updated by the study team

2025-08-03

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.
• 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.

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

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University of St. Louis — St Louis, Missouri, United States
• NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• The Ohio State University/Wexner Medical Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Intermountain Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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