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Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection (UTI-cIAI)

26 giugno 2026 aggiornato da: Xianqiang Chen, Fujian Medical University Union Hospital

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a single-center, randomized, single-blind, three-arm parallel-group superiority pilot clinical trial performed at Fujian Medical University Union Hospital. Randomization sequence is generated with SAS 9.3 software, and random grouping is implemented by sealed envelope method at a 1:1:1 allocation ratio (low-dose ulinastatin : high-dose ulinastatin : normal saline control =1:1:1). A total of 165 participants are planned, with 55 subjects in each group after accounting for an anticipated 10% dropout rate.

All enrolled patients are adults aged ≥18 years diagnosed with complicated intra-abdominal infection (cIAI) within 48 hours, confirmed by clinical manifestation, laboratory tests and abdominal imaging, accompanied by SOFA score ≥2. Subjects with severe immunodeficiency, end-stage liver or renal disease, malignancy, pregnancy, hypersensitivity to ulinastatin and other severe comorbidities are excluded. Written informed consent is obtained prior to any study-related procedures.

All participants receive standardized routine management including surgical source control, antibacterial therapy and organ function supportive treatment. Intervention regimens last for consecutive 5 days via intravenous drip: low-dose group receives ulinastatin 100,000 IU three times daily diluted in 100 mL normal saline; high-dose group receives ulinastatin 300,000 IU three times daily diluted in 100 mL normal saline; control group receives equal volume of sterile normal saline three times daily as placebo. For patients with progressive organ dysfunction after 24-48 hours without improvement, rescue high-dose ulinastatin is allowed per investigator's clinical judgment.

Primary endpoint is the absolute change of Systemic Immune-Inflammation Index (SII) from baseline to treatment Day 5. Secondary endpoints include dynamic changes of CRP, PCT, IL-6, NLR, PLR, LMR, CLR, CD4⁺/CD8⁺ T cell counts at Days 1,3,5 and 7; sequential SOFA score changes; cumulative incidence of new organ failure within 7 and 14 days; ICU and total hospital stay duration; reoperation rate, secondary infection rate, in-hospital and 28-day all-cause mortality. Subgroup analyses are preset stratified by operation type, pathogenic bacteria (multidrug-resistant pathogen or candidiasis) and baseline disease severity (MPI/SOFA score).

All adverse events (AEs) from informed consent to 4 weeks after final study medication are documented following CTCAE Version 5.0. All serious adverse events (SAEs) must be reported to the sponsor (Techpool Bio-Pharma Co., Ltd.) within 24 hours. Study will be prematurely terminated if excessive unexpected severe adverse events occur or interim analysis demonstrates no meaningful intergroup difference in primary inflammatory markers. Study monitoring, source document verification and data management are conducted in accordance with GCP and Declaration of Helsinki principles.

Tipo di studio

Interventistico

Iscrizione (Stimato)

165

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Fujian
      • Fuzhou, Fujian, Cina, 350001
        • Fujian Medical University Union Hospital
        • Contatto:
        • Investigatore principale:
          • QinYong Weng, MD
        • Sub-investigatore:
          • XianQiang Chen, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Able to provide written informed consent voluntarily.
  2. Age ≥ 18 years old, any gender.
  3. 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.
  4. Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patients with active malignant tumors, pregnancy, or severe psychiatric disorders.
  4. American Society of Anesthesiologists (ASA) physical status grade IV or above.
  5. Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points.
  6. Critically ill patients with expected death within 48 hours after admission.
  7. Known allergy to ulinastatin or any ingredients of the study preparation.
  8. Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
Sperimentale: 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.
Droga: ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
Comparatore placebo: 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.
Droga: Normal Saline (0.9% NaCl)
Equal-volume 0.9% normal saline iv tid×5d as placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5
Lasso di tempo: Baseline (before treatment), Day 5
The Systemic Immune-Inflammation Index (SII) is calculated from routine blood test results as platelet count multiplied by neutrophil count divided by lymphocyte count. The mean change in SII values from baseline to Day 5 will be compared across the three groups to assess the immunomodulatory effect of ulinastatin on systemic immune-inflammatory status in patients with complicated intra-abdominal infection.
Baseline (before treatment), Day 5

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 48 Hours
Lasso di tempo: Baseline, 48 hours
The Systemic Immune-Inflammation Index (SII) is calculated from routine blood test results as platelet count multiplied by neutrophil count divided by lymphocyte count. We will calculate the mean change in SII at 48 hours relative to baseline, and compare these changes among the three treatment groups to evaluate the sustained anti-inflammatory and immunomodulatory effects of ulinastatin.
Baseline, 48 hours
Mean change from baseline in C-reactive protein (CRP) at Day 1, Day 3, Day 5
Lasso di tempo: Baseline, Day 1, Day 3, Day 5
Serum CRP levels will be measured at scheduled time points. Changes from baseline will be compared among groups to evaluate inflammatory status.
Baseline, Day 1, Day 3, Day 5
Mean change from baseline in Interleukin-6 (IL-6) at Day 1, Day 3, Day 5
Lasso di tempo: Baseline, Day 1, Day 3, Day 5
Serum IL-6 levels will be measured at scheduled time points. Changes from baseline will be compared among groups to evaluate inflammatory status.
Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+ T cell count at Day 1, Day 3, Day 5
Lasso di tempo: Baseline, Day 1, Day 3, Day 5
Peripheral CD4+ T cell count will be measured at scheduled time points. Changes from baseline will be compared among groups.
Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+/CD8+ T cell ratio at Day 1, Day 3, Day 5
Lasso di tempo: Baseline, Day 1, Day 3, Day 5
CD4+/CD8+ ratio will be calculated at scheduled time points. Changes from baseline will be compared among groups.
Baseline, Day 1, Day 3, Day 5
Mean change from baseline in Sequential Organ Failure Assessment (SOFA) total score at Day 3, Day 5, Day 7
Lasso di tempo: Baseline, Day 3, Day 5, Day 7
The full name of the scale is Sequential Organ Failure Assessment (SOFA) score. The score ranges from a minimum of 0 to a maximum of 24. Higher SOFA scores indicate worse organ dysfunction and poorer clinical outcomes. SOFA scores will be assessed at baseline and follow-up time points. Score changes will be compared to evaluate organ function improvement.
Baseline, Day 3, Day 5, Day 7
Cumulative incidence of new-onset organ failure at Day 7
Lasso di tempo: Up to Day 7
New-onset organ failure is defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of ≥2 points from baseline. The cumulative incidence of new organ failure occurring within 7 days after treatment initiation will be calculated and compared across the three study groups.
Up to Day 7
Correlation coefficients between serial immune-inflammatory marker changes and 28-day all-cause mortality
Lasso di tempo: Baseline, Day 1, Day 3, Day 5, up to Day 28
Serial dynamic values of systemic immune-inflammatory markers, including Systemic Immune-Inflammation Index (SII), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Lymphocyte-to-Monocyte Ratio (LMR), and CRP-to-Lymphocyte Ratio (CLR), will be collected from baseline to Day 5. Pearson correlation analysis will be performed to evaluate the correlation coefficients between dynamic changes of these markers and 28-day all-cause mortality.
Baseline, Day 1, Day 3, Day 5, up to Day 28
Proportion of participants with 28-day all-cause mortality
Lasso di tempo: Up to Day 28
Vital status followed up to Day 28 after randomization. The percentage of participants who die from any cause within 28 days will be reported and compared between groups.
Up to Day 28
Incidence of adverse events during treatment
Lasso di tempo: From the start of intervention to 4 weeks after the last study drug administration
All adverse events and serious adverse events occurring during the treatment and follow-up period will be recorded in detail. The incidence, severity and correlation with study drugs will be analyzed to evaluate the safety profile of ulinastatin.
From the start of intervention to 4 weeks after the last study drug administration

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fujian Medical University Union Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 ottobre 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

30 giugno 2028

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

29 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FJXH-2026-0506

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be made publicly available for this clinical trial. Relevant study protocol, aggregate clinical outcome results, and summary analysis data may be published in peer-reviewed journals or presented at academic conferences after the completion of the trial. Data access is restricted to the study research team only due to institutional and participant privacy requirements.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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