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SepsisNCT05875740

Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study

An observational study of Sepsis and Inflammatory Response, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Sepsis, Inflammatory Response
How many people
80 participants
Where
1 siteChina
Study dates
6 Sep 2023to 30 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: patients with sepsis defined based on Sepsis 3.0 criteria

Who may be able to join

  • Patients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; No sedative drugs with elimination half-life were used before inclusion in the study; Patients and/or their family members know and agree to participate in the trial.

Who cannot join

  • History of solid organ or bone marrow transplantation; Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma; Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc); Pregnancy or lactation; Chronic nephrosis; Severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; Patients and/or their family members refuse to participate in the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430022

    Jiancheng Zhang, Dr., +8613554105815, zhjcheng1@126.com

    Jiancheng Zhang, Dr.

    Recruiting

Other trials in China

About this study

Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis.

Single-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice.

This observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.

Keywords
sepsis, CD8+ T cell, central memory CD8+ T cell, inflammatory response
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05875740
Study groupRoleWhat they receive
septic patientspatients with sepsis defined based on Sepsis 3.0 criteria within 24 hours after admission
healthy control grouphealthy adults

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute number of CD8+T subsets in the peripheral blood (0 hour)

    CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells

    Measured: 0 hour after study inclusion

  2. Absolute number of CD8+T subsets in the peripheral blood (24 hours)

    CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells

    Measured: 24 hours after study inclusion

  3. Absolute number of CD8+T subsets in the peripheral blood (48 hours)

    CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells

    Measured: 48 hours after study inclusion

  4. Absolute number of CD8+T subsets in the peripheral blood (72 hours)

    CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells

    Measured: 72 hours after study inclusion

  5. proliferation of CD8+T subsets in the peripheral blood (0 hour)

    expression of Ki67 in Tcm and Tem

    Measured: 0 hour after study inclusion

  6. proliferation of CD8+T subsets in the peripheral blood (24 hours)

    expression of Ki67 in Tcm and Tem

    Measured: 24 hours after study inclusion

  7. proliferation of CD8+T subsets in the peripheral blood (48 hours)

    expression of Ki67 in Tcm and Tem

    Measured: 48 hours after study inclusion

  8. proliferation of CD8+T subsets in the peripheral blood (72 hours)

    expression of Ki67 in Tcm and Tem

    Measured: 72 hours after study inclusion

  9. ICU length of stay

    Length of stay in the ICU

    Measured: up to 4 weeks

  10. PD-1 expression of CD8+T subsets in the peripheral blood (24 hours)

    expression of PD-1 in Tcm and Tem

    Measured: 24 hours after study inclusion

Secondary outcomes (18)

  1. Mechanical ventilation time after inclusion

    Patients requiring mechanical ventilation after study inclusion

    Measured: up to 4 weeks

  2. Total hospital length of stay

    Total length of hospital stay

    Measured: up to 4 weeks

  3. In-hospital mortality

    Mortality rates for the entire period of hospitalization

    Measured: up to 4 weeks

  4. 90-day readmission rate

    Percentage of readmission to hospital within 90 days of study inclusion

    Measured: up to 4 weeks

  5. Infection complications

    Pulmonary infection, urinary tract infection, bloodstream infections, etc

    Measured: up to 4 weeks

  6. Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    0-67, higher scores correspond to more severe disease and a higher risk of death

    Measured: 0h after study inclusion

  7. Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    0-67, higher scores correspond to more severe disease and a higher risk of death

    Measured: 24 hours after study inclusion

  8. Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    0-67, higher scores correspond to more severe disease and a higher risk of death

    Measured: 48 hours after study inclusion

  9. Acute physiology and chronic health evaluation (APACHE) Ⅱ score

    0-67, higher scores correspond to more severe disease and a higher risk of death

    Measured: 72 hours after study inclusion

  10. Sequential organ failure assessment (SOFA) score

    0-43, higher scores correspond to more severe sepsis

    Measured: 0 hour after study inclusion

  11. Sequential organ failure assessment (SOFA) score

    0-43, higher scores correspond to more severe sepsis

    Measured: 24 hours after study inclusion

  12. Sequential organ failure assessment (SOFA) score

    0-43, higher scores correspond to more severe sepsis

    Measured: 48 hours after study inclusion

  13. Sequential organ failure assessment (SOFA) score

    0-43, higher scores correspond to more severe sepsis

    Measured: 72 hours after study inclusion

  14. Plasma cytokine levels

    IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α

    Measured: 0 hour after study inclusion

  15. Plasma cytokine levels

    IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α

    Measured: 24 hours after study inclusion

  16. Plasma cytokine levels

    IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α

    Measured: 48 hours after study inclusion

  17. Plasma cytokine levels

    IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α

    Measured: 72 hours after study inclusion

  18. Peripheral blood PMN-MDSC levels

    Frequencies and absolute numbers of total PMN-MDSCs (CD45⁺ CD11b⁺ CD15⁺ CD14- CD33⁺ HLA-DRˡᵒʷ) and the CXCR2⁺ PD-L1⁺ PMN-MDSC subpopulation, assessed via flow cytometry.

    Measured: Within 72 hours of sepsis diagnosis or ICU admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start6 Sep 2023
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875740
Sponsor's protocol ID
ZJC202304
Status last verified
Dec 2025
First submitted
4 May 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Inflammatory Response, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute number of CD8+T subsets in the peripheral blood (0 hour) (time frame: 0 hour after study inclusion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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