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

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT07672496
Status
Not Yet Recruiting

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Conditions

  • Complicated Intra-abdominal Infection (cIAI)
  • Immune Dysfunction
  • Sepsis
  • Systemic Inflammatory Response

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ulinastatin — DRUG
    Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
  • Normal Saline (0.9% NaCl) — DRUG
    Equal-volume 0.9% normal saline iv tid×5d as placebo

Study Details

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.

Key Dates

First listed
Jun 29, 2026
Start date
Oct 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose Ulinastatin
    Intravenous infusion of ulinastatin 100,000 IU, three times daily for 5 consecutive days, diluted in 100 mL normal saline, administered on the basis of standardized routine treatment for complicated intra-abdominal infection.
  • Experimental: High-dose Ulinastatin
    Intravenous infusion of ulinastatin 300,000 IU, three times daily for 5 consecutive days, diluted in 100 mL normal saline, administered on the basis of identical standardized routine treatment.
  • Placebo Comparator: Normal Saline Placebo
    Identical standard routine treatment. Equal volume of 0.9% normal saline infused intravenously three times daily for 5 days as placebo. Rescue high-dose ulinastatin can be given per investigator's judgment for treatment failure patients.

Primary Outcome Measure

Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5 [ Time Frame: Baseline (before treatment), Day 5 ]

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