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OpenTrials
Completed

NCT Number: NCT06181604

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, 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.
  • Admitted or intended to be admitted to the ICU
  • At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of 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 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

Sponsors and collaborators

Lead sponsor

Bluejay Diagnostics, Inc.

Industry

Registry information

Official study title

Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study

Acronym: SYMON

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2023
Registry last updated
Aug 3, 2025

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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