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RECRUITINGPhase 2INTERVENTIONAL

Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Phase II study of Kukoamine B Mesilate in Sepsis Patients

Who May Be Eligible (Plain English)

Who May Qualify: - (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 willing to sign a consent form. Who Should NOT Join This Trial: - (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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

16mg,KB

16mg,Q8h±3min,Day1-Day7

DRUG

Placebos

16mg,Q8h±3min,Day1-Day7

Locations (1)

Peking Union Medical College Hospital
Beijing, Beijing Municipality, China