Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

NCT06654895 | Recruiting

• 1 other identifier: CES-0008
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 5

Brief Summary

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

Sepsis, Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days

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

  Within 28 days after inclusion

Secondary Outcomes (8)

• In-hospital mortality up to 28 days

  Within 28 days after inclusion

• All-cause mortality up to 7 days

  Within 7 days after inclusion

• Sequential Organ Failure Assessment (SOFA) score

  Within 28 days after inclusion

• Hospital length of stay

  Within 28 days after inclusion

• ICU length of stay

  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.
• Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
• Septic shock: 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 drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) 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 (5)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Intermountain Health

Salt Lake City, Utah, 84111, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Affairs

CONTACT

844-327-7078; clinical@bluejaydx.com

Study Design

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

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)