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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 3 trial groupsGroup A: Cohort 1: Systemic inflammatory response or culture ordered
Group B: Cohort 2: Treatment for suspected infection initiated
Group C: Cohort 3: Confirmed or strong evidence of infection
Trial outcomes
Primary outcomes
1
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
Time frame
Within 3 days after inclusionSecondary outcomes
1
In-hospital mortality up to 30 days
Time frame
Within 30 days after inclusion2
In-hospital mortality up to 7 days
Time frame
Within 7 days after inclusion3
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s)
Time frame
Within 3 days after inclusion4
Hospital Length of Stay
Time frame
Participants will be followed up for hospital length of stay for up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov