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

NCT05875740 | Completed DMC

• 1 other identifier: ZJC202304
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Sepsis; Inflammatory Response

Keywords

sepsis; CD8+ T cell; central memory CD8+ T cell; inflammatory response

Outcome Measures

Primary Outcomes (10)

• 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

  0 hour after study inclusion

• 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

  24 hours after study inclusion

• 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

  48 hours after study inclusion

• 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

  72 hours after study inclusion

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

  expression of Ki67 in Tcm and Tem

  0 hour after study inclusion

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

  expression of Ki67 in Tcm and Tem

  24 hours after study inclusion

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

  expression of Ki67 in Tcm and Tem

  48 hours after study inclusion

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

  expression of Ki67 in Tcm and Tem

  72 hours after study inclusion

• ICU length of stay

  Length of stay in the ICU

  up to 4 weeks

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

  expression of PD-1 in Tcm and Tem

  24 hours after study inclusion

Secondary Outcomes (17)

• Mechanical ventilation time after inclusion

  up to 4 weeks

• Total hospital length of stay

  up to 4 weeks

• In-hospital mortality

  up to 4 weeks

• 90-day readmission rate

  up to 4 weeks

• Infection complications

  up to 4 weeks

Study Arms (2)

septic patients

patients with sepsis defined based on Sepsis 3.0 criteria within 24 hours after admission

healthy control group

healthy adults

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with sepsis defined based on Sepsis 3.0 criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 25, 2023
• Study Start: September 6, 2023
• Primary Completion: November 3, 2024
• Study Completion: November 3, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)