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New study aims to crack sepsis diagnosis with advanced genetics

NCT ID NCT07599644

Knowledge-focused Sponsor: Yuebei People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study is collecting blood and urine samples from 1,400 ICU patients in China to find new biological markers for sepsis. Researchers will analyze genes, proteins, and metabolites to build faster and more accurate diagnostic tests. The goal is to help doctors identify sepsis earlier and predict which patients are at higher risk.

What this could mean

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

What this could lead to
If successful, this could lead to faster and more accurate sepsis diagnosis and risk assessment tools for ICU patients.
What could go wrong
This is an observational study, not a treatment trial. The findings may not translate into clinical practice or benefit patients directly.

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 1,400 people

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

Started

Jun 2026

Expected to finish

Dec 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

Critically ill adult patients admitted to the ICU of Yuebei People's Hospital, Shaoguan, Guangdong, China. The study population includes patients with confirmed sepsis (Sepsis-3 criteria) and non-sepsis controls admitted during the same period. All participants had blood samples (plasma and whole blood RNA) and urine samples collected within 24 hours of ICU admission and stored at -80°C.

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 - Sepsis Group: * Age ≥ 18 years * Meets the Sepsis-3 diagnostic criteria: confirmed or suspected infection with an increase in SOFA score of ≥ 2 points from baseline * Develops sepsis within 72 hours of ICU admission * Voluntarily signs the informed consent form (or signed by the legal representative) Inclusion Criteria - Non-Sepsis Group: * Age ≥ 18 years * Hospitalized in the ICU during the same period, with no clear evidence of infection and not meeting the diagnostic criteria for sepsis * Expected ICU treatment time ≥ 24 hours * Voluntarily signs the informed consent form (or signed by the legal representative) Exclusion Criteria: * End-stage chronic organ failure (end-stage renal disease, decompensated liver cirrhosis \[Child-Pugh Grade C\], or chronic heart failure NYHA Class IV), or malignant tumor * Immunocompromised, autoimmune disease, or long-term use of glucocorticoids/immunosuppressants within the past 3 months * Pregnant or postpartum patients * Other conditions deemed unsuitable by the investigator (e.g., terminal state, refusal to cooperate with sample collection, or inability to cooperate with in-hospital and out-of-hospital follow-up)

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Conditions

The condition(s) this trial relates to.

disease infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Sepsis

How to take part

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

  1. The places running it

    1 site. 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

  • Yuebei People's Hospital

    RECRUITING

    Shaoguan, Guangdong, 512026, China

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