Purpose

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.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
VUMC Office of Research
615-322-5000
sponsoredprograms@vumc.org

More Details

Status
Recruiting
Sponsor
Bluejay Diagnostics, Inc.

Study Contact

Clinical Affairs
844-327-7078
clinical@bluejaydx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.