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

26 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

165

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fujian Medical University Union Hospital
        • Kontakt:
        • Huvudutredare:
          • QinYong Weng, MD
        • Underutredare:
          • XianQiang Chen, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
Experimentell: 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.
Läkemedel: ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
Placebo-jämförare: 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.
Läkemedel: Normal Saline (0.9% NaCl)
Equal-volume 0.9% normal saline iv tid×5d as placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 48 Hours
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Fujian Medical University Union Hospital

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 oktober 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

3 juni 2026

Först inskickad som uppfyllde QC-kriterierna

26 juni 2026

Första postat (Faktisk)

29 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FJXH-2026-0506

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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