Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Recruiting

• Conditions: Sepsis, Septic Shock

• Registration Number: NCT06654895
• Lead Sponsor: Bluejay Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2024-11
• Study Start: 2024-11-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.

  • 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.

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 [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days	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
All-cause mortality up to 7 days	Within 7 days after inclusion	Participants will be followed up for 7 days for all-cause mortality
Sequential Organ Failure Assessment (SOFA) score	Within 28 days after inclusion	SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).
Hospital length of stay	Within 28 days after inclusion	Participants will be followed up for hospital length of stay for up to 28 days
ICU length of stay	Within 28 days after inclusion	Participants will be followed up for ICU length of stay for up to 28 days
Vasopressor utilization	Within 28 days after inclusion	Participants will be followed up for use of Vasopressors for up to 28 days
Progression to septic shock	Within 28 days after inclusion	Participants will be followed up for progression to septic shock for up to 28 days
28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock	Within 28 days after inclusion	Participants will be followed up for 28 days for all-cause mortality

Trial Locations

Locations (5)

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

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

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

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

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