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NCT06181604 Clinical Trial

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Sepsis Clinical Trial

— SYMON  

Official title:
Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06181604
Other study ID # CES-0007
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 12, 2024
Est. completion date June 30, 2024

Study information
Verified date May 2024
Source Bluejay Diagnostics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 143
Est. completion date June 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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. - 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. 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.

Study Design

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
Bluejay Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day all-cause mortality Participants will be followed up for 28 days for all-cause mortality Within 28 days after inclusion
Secondary In-hospital mortality up to 28 days Participants will be followed up for 28 days for in-hospital mortality Within 28 days after inclusion
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