Sepsis, Septic Shock
Conditions
Keywords
Interleukin-6, IL-6, Risk Stratification, Infections, Toxemia, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Sepsis, Septic Shock, Shock
Brief 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.
Interventions
None listed
Sponsors
Bluejay Diagnostics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality | Within 28 days after inclusion | Participants will be followed up for 28 days for all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality up to 28 days | Within 28 days after inclusion | Participants will be followed up for 28 days for in-hospital mortality |
Countries
United States
Outcome results
None listed