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Clinical Trials/NCT06181604
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
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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