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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

patients with sepsis defined based on Sepsis 3.0 criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: septic patients
Group B: healthy control group

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
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

Time frame
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

Time frame
72 hours after study inclusion

Secondary outcomes

1

Mechanical ventilation time after inclusion

Patients requiring mechanical ventilation after study inclusion

Time frame
up to 4 weeks
2

Total hospital length of stay

Total length of hospital stay

Time frame
up to 4 weeks
3

In-hospital mortality

Mortality rates for the entire period of hospitalization

Time frame
up to 4 weeks
4

90-day readmission rate

Percentage of readmission to hospital within 90 days of study inclusion

Time frame
up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.