Sepsis
Conditions
Interventions
Experimental group:Administer an experimental drug for injection containing civelestat sodium
Control Group:Administer a placebo without sevelestat sodium
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, regardless of gender; 2. Meet the sepsis 3.0 diagnostic criteria, that is, for patients with confirmed or suspected infection, the sequential organ failure score (SOFA) increased by >= 2 points from the baseline; 3. Confirmed or suspicious bacterial infection (lung, abdominal cavity,blood infection); 4. The occurrence of infection-related organ failure does not exceed 48 hours; organ failure is defined as the sequential organ failure score (SOFA) of at least one organ or system in the circulatory, respiratory, kidney, liver, coagulation, and central nervous system (SOFA) >= 3 Points (that is, a new SOFA score >= 3 points at any point in the screening period); 5. Patients of childbearing age have no parenting plan within the past six months and agree to take effective contraceptive measures during the study period; 6. The patient or legal representative signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant women (positive urine pregnancy test during the screening period) or lactating women; 2. The expected survival time is less than 48h; 3. The patient has end-stage malignant tumor, end-stage lung disease and other end-stage diseases, or has suffered cardiac arrest within 30 days before enrollment; 4. The patient has the following chronic organ insufficiency or immunosuppression (as assessed by the chronic health score based on the APACHE II score): (1) Heart: New York Heart Association cardiac function class IV; (2) Respiratory: Chronic restrictive, obstructive or vascular lung disease resulting in severe limitation of activity, i.e. inability to go upstairs or do housework; or definite chronic hypoxia, CO2 retention, secondary polycythemia vera, severe Pulmonary hypertension (systolic blood pressure > 40 mmHg) or ventilator dependence; (3) Kidney: receive long-term dialysis treatment; (4) Liver: biopsy-proven cirrhosis and definite portal hypertension; previous upper gastrointestinal bleeding due to portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma, jaundice; (5) Immunosuppression: received treatment measures that affect infection resistance (such as immunosuppressive therapy, received radiotherapy or chemotherapy within 6 months, long-term (>=3 weeks of continuous use) and/or recent (within 5 days before screening) Use high-dose hormones (prednisone or equivalent dose >= 0.3 mg/kg/d), or suffer from diseases that affect infection resistance (such as leukemia, lymphoma, AIDS). 5. Received solid organ or bone marrow transplantation in the past; 6. Plant living state; 7. The following conditions occur within 4 weeks before enrollment: (1) Acute pulmonary embolism; (2) Blood transfusion reaction; (3) Acute coronary syndrome. 8. Confirmed or highly suspected active viral hepatitis, or clinically confirmed active tuberculosis; 9. Patients with bradycardia (heart rate below 60 beats per minute); 10. Uncontrolled bleeding in the past 24 hours (clinical judgment requires blood transfusion supporter); 11. Large area burns or chemical burns (III degree burn area > 30% BSA) 12. Mean arterial pressure <65mmHg after adequate fluid resuscitation and vasoactive drug treatment; 13. Acute bone marrow hematopoietic suppression, such as agranulocytosis (ANC<500/mm3); 14. Allergic to the active ingredients of the experimental drug or its excipients; 15. The drug the patient is using may seriously affect the metabolism of the test drug; 16. The patient and (or) legal representative sign a non-rescue order (DNR), or decide to withdraw life support treatment (withdraw) or limit the intensity of life support treatment (withhold) and sign the relevant informed consent; 17. Participated in clinical intervention trials within the past 3 months; 18. The subjects are researchers or their immediate family members, or patients who may have improper informed consent; 19. Patients considered by the investigator to be inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sequential organ failure assessment score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil elastase activity in plasma and alveolar lavage fluid;thrombomodulin;Proportion of patients who died from all causes 28 days after the first dose and who continued to require ICU hospitalization;Proportion of patients who died from all causes 7 days after the first dose;Proportion of patients transferred out of the ICU within 7 days after the first dose;The changes of TNF-a and IL-6 from baseline on the 2, 4, and 8 days after the first administration (within 24 hours after the last administration of D7);The duration of staying and not staying in the ICU within 28 days after the first dose;Secondary infection in the hospital after the first administration;No invasive mechanical ventilation time within 28 days; | — |
Countries
China
Contacts
Public ContactShang You
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed