Validation of IL-6 levels to predict mortality in sepsis patients in the ICU
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
This study is testing if measuring a certain level of a protein called IL-6 in the blood can help doctors predict which ICU patients with sepsis are at higher risk of dying within 28 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Bluejay Diagnostics, Inc. Industry-sponsored |
| Locations | 5 sites (Gainesville, Florida and 4 other locations) |
| Trial ID | NCT06654895 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a specific concentration of interleukin-6 (IL-6) that can predict 28-day mortality in patients diagnosed with sepsis or septic shock who are admitted to the ICU. By measuring IL-6 levels in plasma samples collected within 24 hours of diagnosis, the study seeks to establish a reliable cutoff that can aid in risk stratification for these critically ill patients. The findings could enhance clinical decision-making and improve patient outcomes in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 22 and older who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU.
Not a fit: Patients who are prisoners or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a crucial tool for predicting mortality risk in sepsis patients, potentially leading to better-targeted treatments.
How similar studies have performed: Other studies have explored the role of IL-6 in sepsis, but this specific validation approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gainesville, Florida and 4 other locations
- University of Florida College of Medicine — Gainesville, Florida, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Intermountain Health — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Affairs
- Email: clinical@bluejaydx.com
- Phone: 844-327-7078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.