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

2026年6月26日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

165

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350001
        • Fujian Medical University Union Hospital
        • コンタクト：
        • 主任研究者：
          • QinYong Weng, MD
        • 副調査官：
          • XianQiang Chen, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
実験的：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.
薬：ulinastatin
Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline
プラセボコンパレーター：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.
薬：Normal Saline (0.9% NaCl)
Equal-volume 0.9% normal saline iv tid×5d as placebo

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 48 Hours
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fujian Medical University Union Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月30日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2028年6月30日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年6月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月29日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FJXH-2026-0506

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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