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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Complicated Intra-abdominal Infection (cIAI), Systemic Inflammatory Response, Sepsis, Immune Dysfunction

In brief

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 facts

Study ID

NCT07672496

Run by

Fujian Medical University Union Hospital

People needed

165

Starts

2026-10-30

Expected to finish

2028-06-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written informed consent voluntarily.
• Age ≥ 18 years old, any gender.
• Diagnosed with severe complicated intra-abdominal infection (cIAI) within 48 hours, consistent with the 2025 expert consensus for cIAI diagnosis. Diagnosis is confirmed by clinical symptoms (fever, abdominal pain, distension, etc.), abdominal imaging (CT/ultrasound/MRI), intraoperative findings, or positive pathogen culture of abdominal drainage fluid.
• Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points.

You may not qualify if…

• Severe immune deficiency conditions, including AIDS, prior solid organ or bone marrow transplantation, HIV infection with CD4 count < 200 cells/mm³, long-term high-dose glucocorticoid therapy (prednisone > 20 mg/day), ongoing chemotherapy for malignant tumors, or absolute neutrophil count < 1000 cells/mm³.
• Severe irreversible underlying diseases, including chronic renal failure requiring dialysis, Child-Pugh grade C liver disease, liver disease with severe portal hypertension, or acute liver failure.
• Patients with active malignant tumors, pregnancy, or severe psychiatric disorders.
• American Society of Anesthesiologists (ASA) physical status grade IV or above.
• Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points.
• Critically ill patients with expected death within 48 hours after admission.
• Known allergy to ulinastatin or any ingredients of the study preparation.
• Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China

Full record on ClinicalTrials.gov

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