Sepsis
Conditions
Interventions
Sponsors
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age at onset between 18 and 90 years; 2.Meets the diagnostic criteria for sepsis (Sepsis-3): (i) infection, (ii) life-threatening organ dysfunction with a SOFA score = 2 points; 3.Voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of sepsis for more than 48 hours; 2.Pregnant or lactating women; 3.Severe primary diseases affecting survival, including: uncontrolled malignant tumors with multiple metastases that cannot be resected, hematological diseases, and HIV, etc.; 4.Hepatic or renal dysfunction with a single SOFA score of = 3 points for liver or kidney; 5.Continuous use of immunosuppressants or organ transplant recipients within the past 6 months; 6.Use of steroids within 7 days before enrollment, equivalent to a methylprednisolone dose of = 20 mg/day; 7.Participation in other clinical trials within the past 30 days; 8.Expected to die within 48 hours, patients refusing active treatment (SOFA = 15 or APACHE II = 30); 9.Known allergy to components of the study drug or hypersensitivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality;60-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in liver and kidney function indicators;Changes in GCS score, RASS score, and CAM-ICU score;Changes in APACHE II score;Changes in microcirculation and arterial blood gas indicators;Changes in pulmonary surfactant protein A levels;Duration of ICU stay;Changes in neurological examination indicators;Changes in coagulation indicators;Length of hospital stay;Changes in immune, inflammatory, and metabolic indicators;Changes in traditional Chinese medicine syndromes and scores;Changes in cardiac indicators;Changes in SOFA score; | — |
Countries
China
Contacts
Public ContactBangjiang Fang
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed