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NOT YET RECRUITING
NCT07672496
NA

Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

Complicated intra-abdominal infection (cIAI) triggers dysregulated systemic inflammation and immune paralysis leading to high organ failure and death risk. Ulinastatin is a protease inhibitor with anti-inflammatory properties, but its dose-related effects on immune-inflammation of cIAI patients remain unclear. This single-center single-blinded three-arm randomized controlled pilot study enrolls adult cIAI patients (≥18 years, SOFA≥2) at Fujian Medical University Union Hospital. Eligible patients are randomized into low-dose ulinastatin, high-dose ulinastatin and normal saline placebo groups (1:1:1, 5 days intravenous treatment plus standard care), total planned enrollment 165 participants after 10% dropout adjustment. Primary endpoint is Day5 change of Systemic Immune-Inflammation Index (SII); secondary outcomes include serial inflammatory biomarkers, SOFA variation, organ dysfunction, hospitalization duration, 28-day mortality and safety profiles. This pilot aims to clarify ulinastatin's immune-modulating effect and inform future large RCT design.

Official title: A Single-Center Randomized Controlled Pilot Study on the Effect of Ulinastatin on Systemic Immune and Inflammatory Response in Patients With Complicated Intra-Abdominal Infection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2026-10-30

Completion Date

2028-06-30

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

ulinastatin

Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline

DRUG

Normal Saline (0.9% NaCl)

Equal-volume 0.9% normal saline iv tid×5d as placebo

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China