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A simple blood test might spot sepsis risk before symptoms worsen

NCT ID NCT06885528

Diagnosis Sponsor: Beckman Coulter, 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study tests whether a standard blood test can help predict sepsis in adults arriving at the emergency department. The test measures a marker called monocyte distribution width (MDW), which reflects how varied certain white blood cells are. Researchers will compare MDW results with doctors' final diagnoses to see how accurately the marker flags patients who develop sepsis. If it works, this could give emergency teams a quick, routine tool to identify high-risk patients earlier.

What this could mean

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

Active substance
Monocyte Distribution Width (MDW) parameter measured from a standard complete blood count with differential test
What this could lead to
If accurate, this could give emergency doctors a fast, routine blood test to flag patients at risk of sepsis, enabling earlier treatment and better outcomes.
What could go wrong
The test may not be accurate enough in all patient groups, and the study is observational, so it cannot prove that using MDW improves patient outcomes.

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

524 people

The number who actually took part.

Started

Jun 2025

Finished

Jul 2026

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

All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED

Ages

18 to 89 years

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: * Adults (18 to 89 years) of all races and ethnicities presenting to the ED * Whole Blood venous samples collected in K2EDTA while the patient was in the ED * First CBC w/diff test ordered within 12 hours of presentation to ED as part of their standard medical care * CBC w/diff tested within 2 hours of specimen collection * Subjects with at least ≥12 hours of follow-up in the ED (or inpatient, if admitted) from presentation Exclusion Criteria: * CBC w/diff test ordered after 12 hours of presentation to ED * Subjects previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study) * Subjects discharged from ED \<12 hours from ED presentation * ED Transfer Patients Data Exclusions Post Enrollment: * Samples that have a system generated flag from the Standard of Care (SOC) CBC w/diff testing will be excluded. * Samples with instrument flags, including vote outs and review flags for MDW will also be excluded (i.e. invalid MDW results). * Subjects' data collected with Instrument Quality Control failure(s).

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Sepsis

Contacts and locations

Locations

  • Hackensack University Medical center

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Truman Medical Center

    Kansas City, Missouri, 64108, United States

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