NCT06181604CompletedNot Applicable
Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study
Bluejay Diagnostics, Inc.7 sites in 1 country143 target enrollmentStarted: January 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bluejay Diagnostics, Inc.
- Enrollment
- 143
- Locations
- 7
- Primary Endpoint
- 28-day all-cause mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- 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.
- •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.
Outcomes
Primary Outcomes
28-day all-cause mortality
Time Frame: Within 28 days after inclusion
Participants will be followed up for 28 days for all-cause mortality
Secondary Outcomes
- In-hospital mortality up to 28 days(Within 28 days after inclusion)
Investigators
Study Sites (7)
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