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Symphony IL-6 Monitoring for Sepsis in the ICU

This study is looking at a specific level of IL-6 (interleukin-6, a protein in your body that can increase during inflammation) to see if it can predict how well patients with sepsis or septic shock will do. Sepsis is a life-threatening condition caused by your body's response to an infection. The study aims to confirm if a certain IL-6 level can help doctors understand the risk of death within 28 days for adult patients (22 years or older) admitted to the ICU with sepsis or septic shock. The goal is to enroll about 700 participants. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include about 700 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 28 days after joining the study to track their health outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06654895

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Active, Not Recruiting
Not specifiedAges 22+Observational
Bluejay Diagnostics, Inc.
~700 participants
Updated 2026-08-19 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
Measured over Within 28 days after inclusion

Conditions

Sepsis, Septic Shock

Explore related trials

SepticemiaSeptic Shock

Where it's being run

5 sites across 5 states
Florida1
Massachusetts1
North Carolina1
Tennessee1
Utah1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Prisoners or imprisonment at time of enrollment
Prior enrollment into this study
Informed consent as approved by IRB is unable to be obtained.

What this trial measures

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

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