efficacy and safety of kukoamine b mesilate in sepsis patients

Conditions: Sepsis

Summary: phase ii study of kukoamine b mesilate in sepsis patients

to assess efficacy,safety,pharmacokinetics 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 lung disease and other end-stage diseases, or had acardiac arrest，acute pulmonary embolism，blood transfusion response and acute coronary syndrome within 4 weeks prior to enrollment; * (4) the patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the apache ii score) : 1) heart: new york heart association cardiac function iv; 2) breathing: chronic obstructive, obstructive, or vascular lung disease can lead to severe restrictions on activities, i.e. the inability to go upstairs or to do housework; or clear chronic hypoxia, co2 retention, secondary real erythrocyte, severe pulmonary hypertension (mpap\> 40 mmhg) or respiratory muscle dependence; 3) kidneys: receiving long-term dialysis; 4) liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; the upper digestive tract hemorrhage caused by portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma; 5) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiotherapy or chemotherapy within 6 months, long-term (continuous use ≥3 weeks) use of glucocorticoids or recent (within 5 days before screening) cumulative use of prednisone or equivalent dose ≥100mg , or sickness impact resistance to infection, such as leukemia, lymphoma and aids); * (5) previous solid organ or bone marrow transplantation; * (6) plant survival status; * (7) confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity , or clinically confirmed active tuberculosis; * (8) patients with sinus bradycardia (less than 60 per minute); * (9) uncontrolled bleeding in the past 24 hours（clinical judgment requires transfusion support）; * (10) large area burns or chemical burns (iii degree burns area \> 30% bsa); * (11) the average arterial pressure was \< 65 mmhg after adequate liquid resuscitation and vasoactive drug therapy; * (12) acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (anc \< 500 / mm3); * (13) allergic to the active ingredient or its auxiliary materials; * (14) the medication patients are using may severely affect the metabolism of the drug; * (15) patients and (or) guardians have signed a do not rescue (dnr), or decided to withdraw life support (withdraw) or restrict life support for the intensity (withhold) and sign the informed consent form; * (16) participated in clinical intervention test in 3 months; * (17) the subject is a researcher or his immediate family member, or may have improper informed consent; * (18) the investigator considers it inappropriate for the patient to participate in this test.