Sepsis
Conditions
Interventions
Control group (Patients demonstrating no significant quantitative or functional alterations in blood cells during early-stage sepsis):None
Experimental group (Patients demonstrating significant quantitative and functional alterations in blood cells during early-stage sepsis):None
Sponsors
Zhongshan Hospital ( Xiamen ) , Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Based on the International Sepsis Definition (Sepsis-3), the patient meets the diagnostic criteria for sepsis. SOFA (Sequential Organ Failure Assessment) score >=2 points. Confirmed or highly suspected source of infection is present. 2. White blood cell (WBC) count: 12.0×10?/L. C-reactive protein (CRP) >100 mg/L. Serum procalcitonin (PCT) >0.5 ng/mL. 3. Clear history of infection (such as pneumonia, abdominal infection, or urinary tract infection) prior to hospitalization. Disease course: Onset =48 hours. No history of immunosuppressive agents or long-term glucocorticoid therapy. Not participating in other clinical trials prior to enrollment. 4. Age: 18 to 80 years. Gender: Any. Possesses full informed consent capacity and voluntarily participates in the study. No major comorbidities (e.g., advanced malignancies, end-stage liver disease). No severe hematological disorders (e.g., aplastic anemia, acute leukemia).
Exclusion criteria
Exclusion criteria: 1. Received immunosuppressive agents or biological agents (e.g., cyclophosphamide, methotrexate) within 30 days prior to enrollment. 2. Long-term systemic glucocorticoid use (>=0.5 mg/kg/day prednisone or equivalent). 3. Diagnosed with advanced malignant tumor and life expectancy less than 3 months. 4. Patients with end-stage liver disease (Child-Pugh class C) or decompensated cirrhosis. 5. Chronic renal failure requiring long-term hemodialysis. 6. Patients with severe cardiovascular disease (e.g., NYHA Class III-IV heart failure or acute myocardial infarction within the past 6 months). 7. History of severe hematologic disorders (e.g., leukemia, aplastic anemia). 8. Patients with HIV infection or other clinically significant immunosuppressive conditions. 9. Pregnant or lactating women. 10. Patients with severe psychiatric disorders or cognitive impairment that preclude comprehension of or compliance with the study protocol. 11. Received massive blood transfusion or plasma exchange therapy within 48 hours prior to enrollment. 12. Critically ill patients with life-threatening conditions and an expected survival of less than 48 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SOFA score;30-day all-cause mortality;ICU length of stay (ICU-LOS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune functional recovery status;Duration of mechanical ventilation;Incidence of infection-associated complications;90-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactWang Yuting
Zhongshan Hospital ( Xiamen ) , Fudan University
Outcome results
None listed