sepsis induced coagulation
Conditions
Interventions
Test Group:Sivelestat, 2 mL (600 LSU), administered once daily by intravenous injection.
Control Group:2 mL of 5% glucose solution, administered once daily by intravenous injection.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. The patient meets the Sepsis-3.0 criteria (confirmed infection + SOFA score >= 2); 2. Meets the SIC diagnostic criteria (SIC score >= 4)
Exclusion criteria
Exclusion criteria: 1. Age under 18 years; 2. Pregnant or breastfeeding women; 3. Known hypersensitivity to Sivelestat or related compounds: History of allergy to Sivelestat or similar drugs (e.g., heparin, low molecular weight heparin); History of severe drug allergy or allergic diseases (e.g., anaphylactic shock); 4. High risk of bleeding: Active bleeding or recent significant bleeding history (e.g., gastrointestinal bleeding, intracranial hemorrhage); Bleeding tendency due to hematologic disorders (e.g., hemophilia, severe thrombocytopenia); Known coagulation disorders (e.g., clotting factor deficiency, severe liver disease leading to coagulopathy); 5. Recent surgical history: Major surgery within 1 month prior to enrollment (especially brain, spinal, or ophthalmic surgery); Patients scheduled for upcoming surgical procedures; Unhealed surgical wounds; 6. Severe hepatic or renal dysfunction: Severe hepatic impairment (e.g., Child-Pugh Class C cirrhosis, ALT/AST > 3× upper limit of normal); Severe renal impairment (e.g., eGFR < 30 mL/min/1.73m² or requiring dialysis); 7. Concomitant use of other anticoagulant or antiplatelet drugs: Current use of anticoagulants (e.g., warfarin, rivaroxaban, dabigatran) or antiplatelet agents (e.g., aspirin, clopidogrel); 8. Participation in other drug clinical trials within the past 3 months; 9. Patients with advanced malignancy or end-stage disease, or those considered to be in a terminal condition by the investigator; 10. Poor compliance with study procedures: Inability to follow up as scheduled or poor treatment adherence (e.g., psychiatric disorders, cognitive impairment); Inability to cooperate with necessary examinations or monitoring required by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality rate;Improvement in the sofa score; | — |
Countries
China
Contacts
Public ContactZhang Dong
The First Hospital of Jilin University
Outcome results
None listed