Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Active, not recruiting

• Conditions: Sepsis; Septic Shock

• Registration Number: NCT06181604
• Lead Sponsor: Bluejay Diagnostics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Study Start: 2024-01-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 143

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day all-cause mortality	Within 28 days after inclusion	Participants will be followed up for 28 days for all-cause mortality

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality up to 28 days	Within 28 days after inclusion	Participants will be followed up for 28 days for in-hospital mortality

Trial Locations

Locations (7)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

NewYork-Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Washington University of St. Louis; 🇺🇸 Saint Louis, Missouri, United States

The Ohio State University/Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Intermountain Healthcare; 🇺🇸 Salt Lake City, Utah, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States