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Blood test may predict sepsis death risk within 28 days

NCT ID NCT06654895

Diagnosis Sponsor: Bluejay Diagnostics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study is testing whether measuring a substance called IL-6 in the blood can help predict which patients with sepsis or septic shock are most likely to die within 28 days. Researchers will enroll 700 adults in intensive care units (ICUs) and follow them for 28 days. If the test works, it could give doctors a fast way to identify high-risk patients and tailor their care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IL-6 blood test (diagnostic device)
What this could lead to
If successful, this could give doctors a quick, reliable tool to identify which sepsis patients are at highest risk of dying within 28 days, helping them make faster treatment decisions.
What could go wrong
This is a validation study, not a treatment trial. The test may not prove accurate enough to change patient outcomes, and results may not apply to all hospital settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients diagnosed with sepsis or septic shock, in accordance with the sepsis-3 criteria, admitted or intended to be admitted to the ICU.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients (≥22 years of age) * 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: * Prisoners or imprisonment at time of enrollment * Prior enrollment into this study * Informed consent as approved by IRB is unable to be obtained.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease with sepsis Inflammation Pathologic Processes Sepsis Shock Systemic Inflammatory Response Syndrome toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis, septic shock

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Intermountain Health

    Salt Lake City, Utah, 84111, United States

  • University of Florida College of Medicine

    Gainesville, Florida, 32610, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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