Pediatric Sepsis
Conditions
Interventions
Control group:20 mL normal saline, administered every 8 hours for 7 days, via intravenous drip (IV drip) or intravenous injection (IV)
Test group:Ulinastatin for Injection
Dosage: 20,000 U/kg per day (administered every 8 hours, reconstituted with 20 mL normal saline) for 7 days, via intravenous drip (IV drip) or intravenous injectio
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. 28d=2 points.·
Exclusion criteria
Exclusion criteria: This study excludes patients who meet any of the following criteria: 1. Received immunomodulatory therapy (e.g., Xuebijing, thymosin) within two months prior to enrollment; 2. Used high-dose non-steroidal anti-inflammatory drugs within two days before disease onset; or glucocorticoids (methylprednisolone) at a daily dosage of >5 mg/kg or >500 mg/day; 3. Patients who have opted to discontinue treatment or decline comprehensive life support measures; 4. Prior use of ulinastatin before enrollment; 5. History of allergy to ulinastatin or any of its components; 6. Children in the terminal stage of disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite endpoint includes death within 28 days after randomization and the persistence of at least one organ failure on day 7 after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in TM levels;Length of stay in ICU;Number of days survived without life-support interventions such as renal replacement therapy, mechanical ventilation, and vasopressors (observation period: day 0 to day 28);Changes in cytokine levels;Changes in pSOFA and/or Phoenix Sepsis Score(PSS) scores ;Changes in blood lactate levels ;Changes in WBC, CRP, PCT, LDH levels;Changes in the amount of fluid coming in and out;Changes in glucocorticoid use; | — |
Countries
China
Contacts
Public ContactBai Zhenjiang
Children's Hospital of Soochow University
Outcome results
None listed