Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-06-30

Brief Summary

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Phase II study of Kukoamine B Mesilate in Sepsis Patients

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Detailed Description

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To Assess Efficacy,Safety,Pharmacokinetics of Kukoamine B Mesilate in Sepsis Patients

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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16mg,KB

Group A:16mg,Q8h±3min,Day1-Day7

Group Type EXPERIMENTAL

16mg，KB

Intervention Type DRUG

16mg,Q8h±3min,Day1-Day7

Placebos

Group B:Placebos,Q8h±3min,Day1-Day7

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

16mg,Q8h±3min,Day1-Day7

Interventions

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16mg，KB

16mg,Q8h±3min,Day1-Day7

Intervention Type DRUG

Placebos

16mg,Q8h±3min,Day1-Day7

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No