NCT Number: NCT05875740
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Wuhan, Hubei, 430022, China
Location status: Recruiting
Jiancheng Zhang, Dr.
CONTACT
Jiancheng Zhang, Dr.
PRINCIPAL_INVESTIGATOR
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.
Time frame: 0 hour after study inclusion
CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells
Time frame: 24 hours after study inclusion
CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells
Time frame: 48 hours after study inclusion
CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells
Time frame: 72 hours after study inclusion
CD3+ CD8+ CCR7+ CD127high CD62L+ CD27high CD45RA- cells，and CD3+ CD8+ CCR7- CD127- CD62L- CD27low CD45RA- cells
Time frame: 0 hour after study inclusion
expression of Ki67 in Tcm and Tem
Time frame: 24 hours after study inclusion
expression of Ki67 in Tcm and Tem
Time frame: 48 hours after study inclusion
expression of Ki67 in Tcm and Tem
Time frame: 72 hours after study inclusion
expression of Ki67 in Tcm and Tem
Time frame: up to 4 weeks
Length of stay in the ICU
Time frame: 24 hours after study inclusion
expression of PD-1 in Tcm and Tem
Time frame: up to 4 weeks
Patients requiring mechanical ventilation after study inclusion
Time frame: up to 4 weeks
Total length of hospital stay
Time frame: up to 4 weeks
Mortality rates for the entire period of hospitalization
Time frame: up to 4 weeks
Percentage of readmission to hospital within 90 days of study inclusion
Time frame: up to 4 weeks
Pulmonary infection, urinary tract infection, bloodstream infections, etc
Time frame: 0h after study inclusion
0-67, higher scores correspond to more severe disease and a higher risk of death
Time frame: 24 hours after study inclusion
0-67, higher scores correspond to more severe disease and a higher risk of death
Time frame: 48 hours after study inclusion
0-67, higher scores correspond to more severe disease and a higher risk of death
Time frame: 72 hours after study inclusion
0-67, higher scores correspond to more severe disease and a higher risk of death
Time frame: 0 hour after study inclusion
0-43, higher scores correspond to more severe sepsis
Time frame: 24 hours after study inclusion
0-43, higher scores correspond to more severe sepsis
Time frame: 48 hours after study inclusion
0-43, higher scores correspond to more severe sepsis
Time frame: 72 hours after study inclusion
0-43, higher scores correspond to more severe sepsis
Time frame: 0 hour after study inclusion
IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α
Time frame: 24 hours after study inclusion
IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α
Time frame: 48 hours after study inclusion
IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α
Time frame: 72 hours after study inclusion
IL-2、IL-4、IL-6、IL-10、IL-17A、IFN-γ、TNF-α
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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
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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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