Sepsis Infections and Infestations
Conditions
Interventions
After completing screening measurements and acquiring written informed consent, eligible participants will be randomized in a 1:1 ratio to either the Ulinastatin group or the control group through an
Sponsors
Guangdong Techpool Bio-pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 28 days < age = 18 years 2. There is clear evidence of infection 3. Meet diagnostic criteria for sepsis: infection + pSOFA and/or Phoenix Sepsis Score (PSS) =2
Exclusion criteria
Exclusion criteria: 1. Received immunomodulatory therapy within 2 months before enrollment, such as Xuebijing and thymosin 2. Use of high-dose non-steroidal anti-inflammatory drugs within two days before enrollment; The daily dose of glucocorticoids > 5 mg/kg or greater than 500 mg/day within two days before enrollment 3. Palliative treatment without enough life support treatment 4. Receive ulinastatin treatment prior to enrollment 5. Previous history of allergy to ulinastatin or any of its components 6. Children with terminal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of 28-day mortality and/or presence of at least one organ failure on day 7 after randomization (pSOFA =2 and/or Phoenix Sepsis Score=2 for each organ system) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes were measured using patients’ hospitalization records and laboratory indexes: 1. Thrombomodulin levels on randomization days 0, 1, 2 and 7 2. Length of ICU stay to day 28 after randomization 3. Days of survival without life-support interventions to day 28 after randomization 4. Cytokine levels on randomization days 0, 1, 2 and 7 5. pSOFA and/or Phoenix Sepsis Score scores on randomization days 0, 1, 2 and 7 6. Blood lactate levels on randomization days 0, 1, 2 and 7 7. WBC, CRP, PCT, LDH levels on randomization days 0, 1, 2 and 7 8. 24-hour fluid output and intake within the first 7 days of randomization 9. Cumulative use of steroids within the first 7 days of randomization (equivalent to methylprednisolone) | — |
Countries
China
Contacts
Public ContactShuiyan;Zhenjiang Wu;Bai
;
Outcome results
None listed