Clinical trial NCT06654895: Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Official title: Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis, Septic Shock
Keywords: Interleukin-6
IL-6
Risk Stratification
Infections
Toxima
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Sepsis
Septic Shock
Shock
Lead sponsor: Bluejay Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 700
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
timeFrame: Within 28 days after inclusion
Secondary outcomes:
measure: In-hospital mortality up to 28 days
timeFrame: Within 28 days after inclusion
measure: All-cause mortality up to 7 days
timeFrame: Within 7 days after inclusion
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: Within 28 days after inclusion
measure: Hospital length of stay
timeFrame: Within 28 days after inclusion
measure: ICU length of stay
timeFrame: Within 28 days after inclusion
measure: Vasopressor utilization
timeFrame: Within 28 days after inclusion
measure: Progression to septic shock
timeFrame: Within 28 days after inclusion
measure: 28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
timeFrame: Within 28 days after inclusion
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Winston Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Intermountain Health
state: Utah
Study officials:
References: