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NCT Number: NCT06654895

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

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.

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Key information

Conditions

Sepsis, Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida College of Medicine, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days

    Time frame: Within 28 days after inclusion

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

Secondary outcomes

  1. In-hospital mortality up to 28 days

    Time frame: Within 28 days after inclusion

    Participants will be followed up for 28 days for in-hospital mortality

  2. All-cause mortality up to 7 days

    Time frame: Within 7 days after inclusion

    Participants will be followed up for 7 days for all-cause mortality

  3. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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).

  4. Hospital length of stay

    Time frame: Within 28 days after inclusion

    Participants will be followed up for hospital length of stay for up to 28 days

  5. ICU length of stay

    Time frame: Within 28 days after inclusion

    Participants will be followed up for ICU length of stay for up to 28 days

  6. Vasopressor utilization

    Time frame: Within 28 days after inclusion

    Participants will be followed up for use of Vasopressors for up to 28 days

  7. Progression to septic shock

    Time frame: Within 28 days after inclusion

    Participants will be followed up for progression to septic shock for up to 28 days

  8. 28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock

    Time frame: Within 28 days after inclusion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Affairs

CONTACT

[email protected]

844-327-7078

Sponsors and collaborators

Lead sponsor

Bluejay Diagnostics, Inc.

Industry

Registry information

Acronym: SYMON II

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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