Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
NCT ID: NCT06654895
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2024-11-12
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Prior enrollment into this study
* Informed consent as approved by IRB is unable to be obtained.
22 Years
ALL
No
Sponsors
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Bluejay Diagnostics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Florida College of Medicine
Gainesville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Health
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Office of Research College of Medicine
Role: primary
Clinical Affairs
Role: primary
Clinical Translation Science Institute
Role: primary
VUMC Office of Research
Role: primary
Clinical Affairs
Role: primary
Other Identifiers
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CES-0008
Identifier Type: -
Identifier Source: org_study_id