Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- Bluejay Diagnostics, Inc.
- Study ID
- NCT06654895
- Status
- Recruiting
Conditions
- Sepsis, Septic Shock
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Nov 12, 2024
- Status verified
- Dec 2025
- Primary completion
- Aug 30, 2026
- Completion
- Aug 30, 2026
Study Design
- Enrollment
- 700 participants (estimated)
Primary Outcome Measure
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days [ Time Frame: Within 28 days after inclusion ]
Central Contacts
- Clinical Affairs844-327-7078
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Clinical Affairs |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | |
| Intermountain Health | Salt Lake City | Utah | 84111 | Clinical Affairs |
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