Clinical trial NCT05875740: Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study
Official title: Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Inflammatory Response
Keywords: sepsis
CD8+ T cell
central memory CD8+ T cell
inflammatory response
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with sepsis defined based on Sepsis 3.0 criteria

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute number of CD8+T subsets in the peripheral blood (0 hour)
timeFrame: 0 hour after study inclusion
measure: Absolute number of CD8+T subsets in the peripheral blood (24 hours)
timeFrame: 24 hours after study inclusion
measure: Absolute number of CD8+T subsets in the peripheral blood (48 hours)
timeFrame: 48 hours after study inclusion
measure: Absolute number of CD8+T subsets in the peripheral blood (72 hours)
timeFrame: 72 hours after study inclusion
measure: proliferation of CD8+T subsets in the peripheral blood (0 hour)
timeFrame: 0 hour after study inclusion
measure: proliferation of CD8+T subsets in the peripheral blood (24 hours)
timeFrame: 24 hours after study inclusion
measure: proliferation of CD8+T subsets in the peripheral blood (48 hours)
timeFrame: 48 hours after study inclusion
measure: proliferation of CD8+T subsets in the peripheral blood (72 hours)
timeFrame: 72 hours after study inclusion
measure: ICU length of stay
timeFrame: up to 4 weeks
measure: PD-1 expression of CD8+T subsets in the peripheral blood (24 hours)
timeFrame: 24 hours after study inclusion
Secondary outcomes:
measure: Mechanical ventilation time after inclusion
timeFrame: up to 4 weeks
measure: Total hospital length of stay
timeFrame: up to 4 weeks
measure: In-hospital mortality
timeFrame: up to 4 weeks
measure: 90-day readmission rate
timeFrame: up to 4 weeks
measure: Infection complications
timeFrame: up to 4 weeks
measure: Acute physiology and chronic health evaluation (APACHE) Ⅱ score
timeFrame: 0h after study inclusion
measure: Acute physiology and chronic health evaluation (APACHE) Ⅱ score
timeFrame: 24 hours after study inclusion
measure: Acute physiology and chronic health evaluation (APACHE) Ⅱ score
timeFrame: 48 hours after study inclusion
measure: Acute physiology and chronic health evaluation (APACHE) Ⅱ score
timeFrame: 72 hours after study inclusion
measure: Sequential organ failure assessment (SOFA) score
timeFrame: 0 hour after study inclusion
measure: Sequential organ failure assessment (SOFA) score
timeFrame: 24 hours after study inclusion
measure: Sequential organ failure assessment (SOFA) score
timeFrame: 48 hours after study inclusion
measure: Sequential organ failure assessment (SOFA) score
timeFrame: 72 hours after study inclusion
measure: Plasma cytokine levels
timeFrame: 0 hour after study inclusion
measure: Plasma cytokine levels
timeFrame: 24 hours after study inclusion
measure: Plasma cytokine levels
timeFrame: 48 hours after study inclusion
measure: Plasma cytokine levels
timeFrame: 72 hours after study inclusion
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: