Sepsis, Septic ShockSYMON IINCT06654895
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
An observational study of Sepsis, Septic Shock, run by Bluejay Diagnostics, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 700 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Florida College of Medicine
Gainesville, Florida, 32610
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Intermountain Health
Salt Lake City, Utah, 84111
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this 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.
- Conditions
- Sepsis, Septic Shock
- Keywords
- Interleukin-6, IL-6, Risk Stratification, Infections, Toxima, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Sepsis, Septic Shock, Shock
- Medical subject headings
- Sepsis, Shock, Septic, Infections, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
Participants will be followed up for 28 days for all-cause mortality
Measured: Within 28 days after inclusion
Secondary outcomes (8)
In-hospital mortality up to 28 days
Participants will be followed up for 28 days for in-hospital mortality
Measured: Within 28 days after inclusion
All-cause mortality up to 7 days
Participants will be followed up for 7 days for all-cause mortality
Measured: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).
Measured: Within 28 days after inclusion
Hospital length of stay
Participants will be followed up for hospital length of stay for up to 28 days
Measured: Within 28 days after inclusion
ICU length of stay
Participants will be followed up for ICU length of stay for up to 28 days
Measured: Within 28 days after inclusion
Vasopressor utilization
Participants will be followed up for use of Vasopressors for up to 28 days
Measured: Within 28 days after inclusion
Progression to septic shock
Participants will be followed up for progression to septic shock for up to 28 days
Measured: Within 28 days after inclusion
28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Participants will be followed up for 28 days for all-cause mortality
Measured: Within 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start12 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bluejay Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654895
- Sponsor's protocol ID
- CES-0008
- Acronym
- SYMON II
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
- ClinicalTrials.gov ID
- NCT06654895
- Acronym / sponsor ID
- SYMON II / CES-0008
- Conditions
- Sepsis, Septic Shock
- Keywords
- Interleukin-6, IL-6, Risk Stratification, Infections, Toxima, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Bluejay Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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 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.
Key exclusion criteria (3 listed)
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
In-hospital mortality up to 28 days
Time frame: Within 28 days after inclusion
All-cause mortality up to 7 days
Time frame: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
Time frame: Within 28 days after inclusion
Hospital length of stay
Time frame: Within 28 days after inclusion
ICU length of stay
Time frame: Within 28 days after inclusion
Vasopressor utilization
Time frame: Within 28 days after inclusion
Progression to septic shock
Time frame: Within 28 days after inclusion
28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Time frame: Within 28 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis, Septic Shock
RecruitingPhase 3
Systematic Adjunction of Vasopressine in Septic Shock
Septic Shock
Not yet recruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
Not yet recruitingObservational study
Neutrophil Activation and NETosis in Sepsis
Sepsis, Septic Shock
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
Not yet recruiting
Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Septic Shock, run by Bluejay Diagnostics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.