Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

NCT06181604 | Completed

• 1 other identifier: CES-0007
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 7

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.

Conditions

Sepsis; Septic Shock

Keywords

Interleukin-6; IL-6; Risk Stratification; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Sepsis; Septic Shock; Shock

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  Participants will be followed up for 28 days for all-cause mortality

  Within 28 days after inclusion

Secondary Outcomes (1)

• In-hospital mortality up to 28 days

  Within 28 days after inclusion

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with sepsis or septic shock, in accordance with the Sepsis-3 criteria, admitted or intended to be admitted to the ICU.

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.

Sponsors & Collaborators

• Bluejay Diagnostics, Inc.: lead

Study Sites (7)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University of St. Louis

St Louis, Missouri, 63110, United States

Location

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University/Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84111, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: January 12, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)