Multicenter Symphony IL-6 Monitoring Sepsis ICU Study (SYMON)

Bluejay Diagnostics

Status: Completed

Conditions: Septic Shock; Sepsis

Study type: Observational

Funder types: Industry

Identifiers

NCT06181604

CES-0007

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.