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 2026-10-01.
Sponsored by Bluejay Diagnostics, Inc. · Observational
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 700 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 diagnosed with sepsis or septic shock, in accordance with the sepsis-3 criteria, admitted or intended to be admitted to the ICU.
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.
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.
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.
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
Participants will be followed up for 28 days for all-cause mortality
Time frame: Within 28 days after inclusion
In-hospital mortality up to 28 days
Participants will be followed up for 28 days for in-hospital mortality
Time frame: Within 28 days after inclusion
All-cause mortality up to 7 days
Participants will be followed up for 7 days for all-cause mortality
Time frame: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).
Time frame: Within 28 days after inclusion
Hospital length of stay
Participants will be followed up for hospital length of stay for up to 28 days
Time frame: Within 28 days after inclusion
ICU length of stay
Participants will be followed up for ICU length of stay for up to 28 days
Time frame: Within 28 days after inclusion
Vasopressor utilization
Participants will be followed up for use of Vasopressors for up to 28 days
Time frame: Within 28 days after inclusion
Progression to septic shock
Participants will be followed up for progression to septic shock for up to 28 days
Time frame: Within 28 days after inclusion
28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Participants will be followed up for 28 days for all-cause mortality
Time frame: Within 28 days after inclusion
Plan to share: No
No publications or documents are linked to this record.
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.