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NCT Number: NCT05875740

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

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Key information

Conditions

Sepsis Infections Inflammation Inflammatory Response Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430022, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 0 hour after study inclusion

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

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

    Time frame: 24 hours after study inclusion

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

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

    Time frame: 48 hours after study inclusion

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

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

    Time frame: 72 hours after study inclusion

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

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

    Time frame: 0 hour after study inclusion

    expression of Ki67 in Tcm and Tem

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

    Time frame: 24 hours after study inclusion

    expression of Ki67 in Tcm and Tem

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

    Time frame: 48 hours after study inclusion

    expression of Ki67 in Tcm and Tem

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

    Time frame: 72 hours after study inclusion

    expression of Ki67 in Tcm and Tem

  9. ICU length of stay

    Time frame: up to 4 weeks

    Length of stay in the ICU

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

    Time frame: 24 hours after study inclusion

    expression of PD-1 in Tcm and Tem

Secondary outcomes

  1. Mechanical ventilation time after inclusion

    Time frame: up to 4 weeks

    Patients requiring mechanical ventilation after study inclusion

  2. Total hospital length of stay

    Time frame: up to 4 weeks

    Total length of hospital stay

  3. In-hospital mortality

    Time frame: up to 4 weeks

    Mortality rates for the entire period of hospitalization

  4. 90-day readmission rate

    Time frame: up to 4 weeks

    Percentage of readmission to hospital within 90 days of study inclusion

  5. Infection complications

    Time frame: up to 4 weeks

    Pulmonary infection, urinary tract infection, bloodstream infections, etc

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

    Time frame: 0h after study inclusion

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

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

    Time frame: 24 hours after study inclusion

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

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

    Time frame: 48 hours after study inclusion

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

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

    Time frame: 72 hours after study inclusion

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

  10. Sequential organ failure assessment (SOFA) score

    Time frame: 0 hour after study inclusion

    0-43, higher scores correspond to more severe sepsis

  11. Sequential organ failure assessment (SOFA) score

    Time frame: 24 hours after study inclusion

    0-43, higher scores correspond to more severe sepsis

  12. Sequential organ failure assessment (SOFA) score

    Time frame: 48 hours after study inclusion

    0-43, higher scores correspond to more severe sepsis

  13. Sequential organ failure assessment (SOFA) score

    Time frame: 72 hours after study inclusion

    0-43, higher scores correspond to more severe sepsis

  14. Plasma cytokine levels

    Time frame: 0 hour after study inclusion

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

  15. Plasma cytokine levels

    Time frame: 24 hours after study inclusion

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

  16. Plasma cytokine levels

    Time frame: 48 hours after study inclusion

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

  17. Plasma cytokine levels

    Time frame: 72 hours after study inclusion

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

  18. Peripheral blood PMN-MDSC levels

    Time frame: Within 72 hours of sepsis diagnosis or ICU admission.

    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.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 25, 2023
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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