Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
ConditionSepsis, Septic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorBluejay Diagnostics, Inc.
About this trial
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Eligibility criteria
Qualifiers
Adult patients (≥22 years of age)
Intent to admit to hospital or admitted to the hospital via the emergency department
At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant).
Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))
Disqualifiers
Prisoners or imprisonment at time of enrollment
Pregnant
Prior enrollment into this study
Informed consent as approved by IRB is unable to be obtained.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
450 Participants
are grouped into 3 trial groupsLocations
5University of Florida College of Medicine32610, GainesvilleFlorida, United States
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States
Wake Forest School of Medicine27157, Winston-SalemNorth Carolina, United States
Vanderbilt University Medical Center37232, NashvilleTennessee, United States
Sponsors and collaborators
Bluejay Diagnostics, Inc.
Lead sponsor
Source ClinicalTrials.gov