Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Description

The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.

Conditions

Sepsis, Septic Shock

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Study Overview

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Study Details

Study overview

The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Condition
Sepsis, Septic Shock
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida College of Medicine, Gainesville, Florida, United States, 32610

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Winston Salem

Wake Forest School of Medicine, Winston Salem, North Carolina, United States, 27157

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Salt Lake City

Intermountain Health, Salt Lake City, Utah, United States, 84111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
  • * Septic shock: sepsis requiring vasopressors and serum lactate levels \>2 mmol/L (18 mg/dL)
  • * Admitted or intended to be admitted to the ICU
  • * At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.
  • * Prisoners or imprisonment at time of enrollment
  • * Prior enrollment into this study
  • * Informed consent as approved by IRB is unable to be obtained.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bluejay Diagnostics, Inc.,

Study Record Dates

2025-11-30