Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II study of Kukoamine B Mesilate in Sepsis Patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Chasesun Pharmaceutical Co., LTD
• Collaborator: Southwest Hospital, China

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.