Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients
Trial Parameters
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Brief Summary
Phase II study of Kukoamine B Mesilate in Sepsis Patients
Eligibility Criteria
Inclusion Criteria: * (1) The age of ≥ 18 years of age and ≤ 85 years of age, gender is not limited; * (2) Meeting the diagnostic criteria for sepsis 3.0, i.e. sequential organ failure score (SOFA) increased by ≥2 points from baseline for patients with confirmed or suspected infection; * (3) Confirmed or suspected bacterial infection (Pulmonary, abdominal，urinary system or hematogenous infections); * (4) Infection-related organ failure does not exceed 48 hours; organ failure is defined as circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory, kidney, liver, coagulation and central nervous system; * (5) Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception; * (6) Patients or guardians signed informed consent. Exclusion Criteria: * (1) Pregnancy or lactation women； * (2) Patients are expected to live less than 48 hours; * (3) Patients had poor control of malignant tumor, end-stage lun