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Scientists probe immune cell shifts in ICU patients to unlock sepsis secrets

NCT ID NCT07680816

Knowledge-focused Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study examines how a type of immune cell called gamma delta T cells adapt and function in critically ill patients, both with and without sepsis. Researchers will compare these cells in healthy people, non-septic ICU patients, and septic ICU patients. The goal is to understand why the immune system sometimes fails in sepsis, which could lead to better treatments.

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 research could point toward new treatments for immune problems in sepsis and critical illness.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct therapies, and findings may not apply to all patients.

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 105 people

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

Started

Jun 2026

Expected to finish

Jul 2027

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

The study population comprises three distinct groups: healthy volunteers, non-septic critically ill patients, and septic critically ill patients admitted to the intensive care unit. Sepsis is defined according to the Sepsis-3 criteria (infection with an acute increase in SOFA score ≥2 points), while critical illness is based on standard ICU admission criteria. All participants must be aged ≥18 years and provide written informed consent (from the participant or a legally authorized representative for those unable to consent). Key exclusion criteria include known immunodeficiency, recent use of T-cell-targeted immunosuppressants or immune checkpoint inhibitors, expected ICU stay \<24 hours, pregnancy, active major bleeding, or inability to obtain consent. Consecutive enrollment will take place at the Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with follow-up through 90 days after enrollment.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Healthy Control Group (NHC): * Age ≥ 18 years. * No acute or chronic major diseases. * Provide written informed consent. 2. Non-septic Critical Illness Group (CI-NS): * Age ≥ 18 years. * Admitted to the ICU and meeting the definition of critical illness. * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points). * Written informed consent provided by the participant or legally authorized representative. 3. Septic Critical Illness Group (CI-Sep): * Age ≥ 18 years. * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points). * Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: * Age \< 18 years. * Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months. * Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \>1 mg/kg/day prednisone equivalent) before ICU admission or within 24 hours after ICU admission. * Use of immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies) within the past 6 weeks. * Expected ICU stay \< 24 hours or imminent risk of death (moribund state). * Pregnancy or breastfeeding. * Active major bleeding. * Inability to obtain informed consent.

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Conditions

The condition(s) this trial relates to.

Critical Illness Dysbiosis inborn mitochondrial metabolism disorder infectious disease with sepsis mitochondrial disease multiple organ dysfunction syndrome Sepsis

As listed by the trial registrant

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

Critical illness Dysbiosis Immunosuppression Mitochondrial diseases MODS Sepsis ΓΔ T cells

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

  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Outside of the US, 430022, China

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