RecruitingNCT06654895
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Sponsor
Bluejay Diagnostics, Inc.
Enrollment
700 participants
Start Date
Nov 12, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 22 Years
Inclusion Criteria6
- 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 Criteria3
- Prisoners or imprisonment at time of enrollment
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06654895