Sepsis
Conditions
Interventions
Ulinastatin treatment group:On the basis of standard treatment, ustertide is administered intravenously at a dose of 300,000 units for 1-2 hours, three times a day, for a continuous treatment of 7 day
Placebo control group:Matched placebo (saline) is administered using the exact same injection method and timing as the standard treatment plus an equal amount of saline placebo.
Sponsors
Chinese General Hospital of the Eastern Theater of the People's Liberation Army (Qinhuai Medical District)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) People greater than or equal to 18 years old and less than or equal to 80 years old. (2) Meet the Sepsis-3.0 criteria specified by the American Society of Critical Care Medicine and the European Society of Critical Care Medicine: 1) Suspected or confirmed infection: clinician diagnosis. 2) Evidence of acute organ dysfunction: for patients without prior chronic organ insufficiency (assuming a baseline SOFA score of 0): SOFA = 2 points in the period from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection; For patients with prior chronic organ insufficiency (SOFA score should be based on baseline): SOFA increased by = 2 points between 48 hours and 24 hours after diagnosis of infection. (3) All had a clear history of trauma and induced sepsis, and the trauma severity rating (ISS) was = 16 points. (4) Sepsis diagnosis time 38 ° C or 90 beats / minute; 3) Respiratory > 20 beats/min or PaCO212×109/L or 12000/µl or 10%). (6) Obtain informed consent signed by the patient or authorized immediate family member
Exclusion criteria
Exclusion criteria: 1. Congestive heart failure NYHA grade 4 heart function, occurrence of cerebrovascular accident or acute coronary syndrome within 3 months, recent hospitalization or cardiac arrest within 7 days, non infectious cardiogenic shock, uncontrolled acute bleeding. 2. Severe chronic liver disease (Child Pugh C-grade), liver parenchymal disease with significant portal hypertension, and acute liver failure. 3. Chronic renal failure, who received dialysis treatment before enrollment. 4. Severe coagulation dysfunction: ISTH-DIC score = 5 points. 5. Significant immune abnormalities/damage present: prior to screening, organ or bone marrow transplantation, moderate to severe leukopenia such as neutrophils<1.5 within the first 3 months × 109/L, received radiotherapy or chemotherapy within 3 months, tested positive for HIV serology, and had active blood/lymphatic system tumors. 6. The study received treatment with Xuebijing, thymosin, or immunoglobulin within the three months prior to enrollment. 7. Other: Allergies to investigational drugs, pregnancy, lactation, participation in other clinical trials within 3 months, and other situations deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definition of 28 day All-cause mortality;Definition of 90 day All-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment;hypersensitive C-reactive protein;procalcitonin;Interleukin 6;Oxygenation index ;Neutrophil to lymphocyte count ratio;pre-thrombotic state;Acute Physiology and Chronic Health Evaluation;Activity of Daily Living;Blood Lactic Acid;Oxygen Saturation;arterial partial pressure of oxygen;Alveolar air-arterial oxygen partial pressure difference;Adverse Event;Serious Adverse Event;temperature;respiratory rate ;blood pressure;pulse;Red blood cell indicators;White blood cell indicators;Platelet indicators;PENTRAXIN-3;Mechanical ventilation time; | — |
Countries
China
Contacts
Public ContactYang zhizhou
Eastern Theater Command General Hospital
Outcome results
None listed