An observational study in Sepsis, Septic Shock, sponsored by Bluejay Diagnostics, Inc.. Recruiting at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Bluejay Diagnostics, Inc. · Observational
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation:
1. Cohort 1 (Systemic inflammatory response or culture ordered):
Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum))
2. Cohort 2 (Treatment for suspected infection initiated):
Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.
3. Cohort 3 (Confirmed or strong evidence of infection):
Exclusion Criteria:
Criterion #1: (2 of the following within 3 hours of sample collection, of which 1 is at least (A or B): A) body temp \>38c or \<36c B) HR \>90bpm C) respiratory rate \>20 breaths/min D) white blood cell count \>12k or \<4k/microliters or over 10% immature forms or bands, OR Criterion #2: order for culture of a body fluid (blood, urine, sputum)
Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered
Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria: Temp \>101F (38.3c) Pneumonia by X-ray or CT Urinalysis with WBC \>10/HPF Intraabdominal-pelvis infection by CT U/S or MRI Skin/soft tissue infection by clinical exam Evidence of meningitis on LP Positive microbiological culture (cultures drawn within 3 days of presentation) Suspected line infection (e.g., redness or pus around the line)
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
Time frame: Within 3 days after inclusion
In-hospital mortality up to 30 days
Time frame: Within 30 days after inclusion
In-hospital mortality up to 7 days
Time frame: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s)
Time frame: Within 3 days after inclusion
Hospital Length of Stay
Time frame: Participants will be followed up for hospital length of stay for up to 30 days
ICU length of stay
Time frame: Within 30 days after inclusion
Bacterial vs viral infection (As assessed by cultures and/or viral testing)
As assessed by cultures and/or viral testing.
Time frame: Within 30 days after inclusion
Progression to septic shock
Participants will be followed up for progression to septic shock for up to 30 days
Time frame: Within 30 days after inclusion
30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Participants will be followed up for 30 days for all-cause mortality
Time frame: Within 30 days after inclusion
Initiation of vasopressor therapy (by hospital discharge or up to 30 days)
Time frame: within 30 days after inclusion
Initiation of renal replacement therapy (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Initiation of mechanical ventilation (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Free days from vasopressor therapy (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Free days from renal replacement therapy (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Free days from mechanical ventilation (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Free days from vasopressor therapy, renal replacement therapy, or mechanical ventilation, (by hospital discharge or up to 30 days)
Time frame: Within 30 days after inclusion
Plan to share: No
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Bluejay Diagnostics, Inc.