Sepsis
Conditions
Interventions
Sponsors
Zhongshan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects themselves or their family members voluntarily participated in the study and signed the informed consent; 2. Aged 18-80, male or female; 3. Sepsis patients who conform to the Sepsis 3.0 standards proposed in accordance with the consensus of international Sepsis experts in 2016, namely, patients with infection or suspected infection, should be treated with Sepsis related Organ Failure Sepsis was diagnosed when Assessment, SOFA) score increased by 2 points from baseline age; (Table 1) 4. The course of disease was less than 24 hours after diagnosis, and the estimated survival time was more than 96 hours.
Exclusion criteria
Exclusion criteria: 1. Congenital or acquired immune deficiency; Active immunosuppression, defined as receiving immunosuppressive drugs or having medical conditions associated with immune deficiency, includes: (1) HIV(AIDS or CD4& LT; 200 cells /mm3); (2) Had received chemotherapy within 6 weeks prior to randomization; (3) Immunosuppressive therapy, including maintenance glucocorticoid therapy (& GT; 40mg/ d prednisolone equivalent dose); (4) Absolute neutrophil count 12); 4. History of malignant tumor (patients with previous basal cell carcinoma of the skin can be included); 5. Undergoing hemodialysis or peritoneal dialysis; 6. Screening of patients with lower limb venous thrombosis or pulmonary embolism in the previous 90 days; 7. Acute myocardial infarction occurred within 30 days prior to screening; 8. Neuromuscular diseases that impair natural ventilation, including, but not limited to, spinal cord injury at C5 or higher, AMyotrophic lateral sclerosis, Guillain-Barre syndrome and myasthenia gravis; 9. Lung transplantation bone marrow transplantation; 10. Patients receiving cardiopulmonary bypass support (ECMO) or high-frequency oscillatory ventilation; 11. Have a history of epilepsy requiring continuous anticonvulsant therapy or have received anticonvulsant therapy within the past 3 years; 12. Hepatitis B, HEPATITIS C, AIDS and syphilis; 13. Female subjects of childbearing age are pregnant and lactation or have pregnancy intention within the last 1 year; 14. Other clinical trials are under way; 15. Patients with difficult to control neuropsychiatric diseases or mental disorders, poor compliance, and unable to cooperate; Inability to understand research protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day case fatality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional status of immune cells;Mechanical ventilation time;ICU time of stay;Total length of stay and total cost;36-item Short-Form, SF-36; | — |
Countries
China
Contacts
Public ContactFang Hao
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed