Sepsis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sepsis patient cohort: (1) Patients diagnosed with sepsis or septic shock within 24 hours after admission to the ICU according to the Sepsis 3.0 guidelines; (2) Age >= 18 years old, gender not limited; (3) The patient or his/her authorized agent/family member fully understands the content of this study and voluntarily signs the written informed consent form for clinical research. 2. Healthy control group cohort: (1) Healthy volunteers whose age and gender were matched with those in the sepsis patient cohort; (2) The results of physical examination and routine laboratory tests (blood routine, liver and kidney function, etc.) are within the normal range. (3) I fully understand the content of this research and voluntarily sign the written informed consent form for clinical research
Exclusion criteria
Exclusion criteria: 1. Sepsis patient cohort: (1) There is a clear background disease or condition that affects immune function, such as: human immunodeficiency virus (HIV) infection; (2) Those who have been taking immunosuppressants for a long time after solid organ or bone marrow transplantation; (3) Those with blood system diseases who have been taking immunosuppressants for a long time; (4) Suffering from primary immunodeficiency diseases; (5) Patients with malignant tumors who are currently receiving or have received chemotherapy or radiotherapy within 3 months prior to enrollment; (6) Those who need to take high-dose glucocorticoids (>15mg/d prednisone or equivalent doses) or immunosuppressants for a long time (>1 month) due to autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.); (7) Pregnant or lactating women; (8) The patient is currently participating in other drug or interventional clinical trials that may affect the results of this study at the same time; (9) The researcher determined that the patient or their authorized agent/family member refused to sign the informed consent form. 2. Healthy control group cohort: (1) Had any acute infectious diseases (such as cold, diarrhea, etc.) within 2 weeks before screening; (2) Have a history of chronic infectious diseases (such as chronic hepatitis B/C, tuberculosis, etc.); (3) Pregnant or lactating women; (4) Have a history of malignant tumors, autoimmune diseases or immune deficiencies; (5) Long-term use of any drugs that may affect immune function (such as glucocorticoids, immunosuppressants, etc.); (6) Have a history of drug abuse or alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune suppression status indicators (including but not limited to absolute lymphocyte count in peripheral blood, HLA-DR expression level on monocytes);Clinical prognosis indicators (including ICU length of stay, total hospital length of stay, 90-day mortality, long-term survival rate);Organ dysfunction assessment (dynamic changes in SOFA score);In-hospital complications (incidence rates of secondary infections, acute respiratory distress syndrome, acute kidney injury, etc.);Incidence rate of persistent inflammation, immunosuppression, and catabolism syndrome (PICS); | — |
Countries
China
Contacts
The first affiliated hostipal of nanchang university