The effect of ulinastatin on sepsis-related organ failure in childre

Phase 3

• Conditions: Sepsis; Infections and Infestations

• Registration Number: ISRCTN15982148
• Lead Sponsor: Guangdong Techpool Bio-pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Last Update Posted: 9 September 2024
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 364

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The following secondary outcomes were measured using patients’ hospitalization records and laboratory indexes:<br>1. Thrombomodulin levels on randomization days 0, 1, 2 and 7<br>2. Length of ICU stay to day 28 after randomization<br>3. Days of survival without life-support interventions to day 28 after randomization<br>4. Cytokine levels on randomization days 0, 1, 2 and 7<br>5. pSOFA and/or Phoenix Sepsis Score scores on randomization days 0, 1, 2 and 7<br>6. Blood lactate levels on randomization days 0, 1, 2 and 7<br>7. WBC, CRP, PCT, LDH levels on randomization days 0, 1, 2 and 7<br>8. 24-hour fluid output and intake within the first 7 days of randomization<br>9. Cumulative use of steroids within the first 7 days of randomization (equivalent to methylprednisolone)