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Can a simple blood test predict sepsis two days early?

NCT ID NCT07796386

Diagnosis Sponsor: Zhujiang Hospital 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study tests whether a blood protein called neprilysin can predict if ICU patients with an infection will develop sepsis within 48 hours. Researchers will measure neprilysin and other biomarkers in blood samples from 488 adults at two hospitals. They will also check microcirculation under the tongue. The goal is to find a reliable early warning sign, so treatment can start sooner and save lives.

What this could mean

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

Active substance
Plasma neprilysin measurement (diagnostic test)
What this could lead to
If neprilysin predicts sepsis early, doctors could start treatment sooner, potentially reducing severe complications and deaths in ICU patients.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The test may not be accurate enough, and results may not apply to all ICU 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 488 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 critically ill participants admitted to the intensive care unit of Zhujiang Hospital, Southern Medical University, with confirmed or suspected infection who do not meet the protocol-defined criteria for sepsis at enrollment. Newly admitted intensive care unit participants will be screened daily.

Ages

18 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: * Age 18 years or older. * Confirmed or suspected infection as assessed by the treating physician based on symptoms, signs, laboratory findings, imaging findings, microbiological findings, or evidence of an infection source, with systemic antimicrobial therapy initiated or planned. * Does not meet the protocol-defined criteria for sepsis at enrollment. In the setting of confirmed or suspected infection, there must be no acute increase of 2 or more points in the Sequential Organ Failure Assessment 2 score from baseline that is attributable to infection. * Expected by the treating physician to remain in the intensive care unit for more than 48 hours after enrollment. * Written informed consent provided by the participant or the participant's legally authorized representative. Exclusion Criteria: * Sepsis diagnosed at intensive care unit admission or fulfillment of the Sepsis-3 criteria at screening. * Insufficient clinical data to determine the baseline SOFA-2 score according to the prespecified assessment criteria. * Patients with limited nursing care (patients for whom active treatment has been withdrawn) * No blood sample is available on the day of enrollment. * Considered unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Infection Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

    Guangzhou, Guangdong, 510280, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

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