ClinicalTrials.gg
CompletedNCT06181604SYMONUpdated Aug 3, 2025

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

An observational study in Sepsis and Septic Shock, sponsored by Bluejay Diagnostics, Inc.. Completed at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Bluejay Diagnostics, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
143
Ages
22 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sepsis
  • Septic Shock

Keywords

  • Interleukin-6
  • IL-6
  • Risk Stratification
  • Infections
  • Toxemia
  • Systemic Inflammatory Response Syndrome
  • Inflammation
  • Pathologic Processes
  • Sepsis
  • Septic Shock
  • Shock
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 143 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Bluejay Diagnostics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients diagnosed with sepsis or septic shock, in accordance with the Sepsis-3 criteria, admitted or intended to be admitted to the ICU.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Prisoners or imprisonment at time of enrollment
  • Prior enrollment into this study
  • as approved by IRB is unable to be obtained.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
143 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 28-day all-cause mortality

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

    Time frame: Within 28 days after inclusion

Secondary outcomes

  1. In-hospital mortality up to 28 days

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

    Time frame: Within 28 days after inclusion

07

Study locations

7 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Washington University of St. Louis
    St Louis, Missouri 63110, United States
  • NewYork-Presbyterian Brooklyn Methodist Hospital
    Brooklyn, New York 11215, United States
  • Wake Forest School of Medicine
    Winston-Salem, North Carolina 27157, United States
  • The Ohio State University/Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Intermountain Healthcare
    Salt Lake City, Utah 84111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jul 2024, 6 months.

Of 202 observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2023
First posted
Dec 26, 2023
StartActual
Jan 12, 2024
Primary completionActual
Jul 12, 2024
CompletionActual
Jul 12, 2024
Last update
Aug 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06181604
Lead sponsor
Bluejay Diagnostics, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2023
Start date
Jan 12, 2024
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024
Last update
Aug 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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