An observational study in Sepsis, Septic Shock, sponsored by Bluejay Diagnostics, Inc.. Active, not recruiting at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 450 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Bluejay Diagnostics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 202 observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bluejay Diagnostics, Inc.