Sepsis, Septic Shock
Conditions
Keywords
Interleukin-6, IL-6, Risk Stratification, Infections, Toxima, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Sepsis, Septic Shock, Shock
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.
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days | 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 |
| All-cause mortality up to 7 days | Within 7 days after inclusion | Participants will be followed up for 7 days for all-cause mortality |
| Sequential Organ Failure Assessment (SOFA) score | Within 28 days after inclusion | SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s). |
| Hospital length of stay | Within 28 days after inclusion | Participants will be followed up for hospital length of stay for up to 28 days |
| ICU length of stay | Within 28 days after inclusion | Participants will be followed up for ICU length of stay for up to 28 days |
| Vasopressor utilization | Within 28 days after inclusion | Participants will be followed up for use of Vasopressors for up to 28 days |
| Progression to septic shock | Within 28 days after inclusion | Participants will be followed up for progression to septic shock for up to 28 days |
| 28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock | Within 28 days after inclusion | Participants will be followed up for 28 days for all-cause mortality |
Countries
United States
Outcome results
None listed