Complicated Intra-abdominal Infection (cIAI)UTI-cIAINCT07672496
Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection
A study testing ulinastatin and Normal Saline (0.9% NaCl) in people with Complicated Intra-abdominal Infection (cIAI) and Systemic Inflammatory Response, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Intra-abdominal Infection (cIAI), Systemic Inflammatory Response, Sepsis
- What is being tested?
- ulinastatin and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
JunRong Zhang, MD, 0591-83357896, foxbaby34@163.com
QinYong Weng, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Complicated Intra-abdominal Infection (cIAI), Systemic Inflammatory Response, Sepsis, Immune Dysfunction
- Being tested
- ulinastatin, Normal Saline (0.9% NaCl)
- Keywords
- immune dysfunction, Complicated intra-abdominal infection, Ulinastatin, SII, inflammation
- Medical subject headings
- Sepsis, Immune System Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
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 group | Role | What they receive |
|---|---|---|
| Low-dose Ulinastatin | Experimental | 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. Receives: Drug: ulinastatin |
| High-dose Ulinastatin | Experimental | 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. Receives: Drug: ulinastatin |
| Normal Saline Placebo | Placebo comparator | 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. Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 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.
Measured: Baseline (before treatment), Day 5
Secondary outcomes (10)
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 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.
Measured: Baseline, 48 hours
Mean change from baseline in C-reactive protein (CRP) at 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.
Measured: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in Interleukin-6 (IL-6) at 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.
Measured: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+ T cell count at 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.
Measured: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+/CD8+ T cell ratio at Day 1, Day 3, Day 5
CD4+/CD8+ ratio will be calculated at scheduled time points. Changes from baseline will be compared among groups.
Measured: 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
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.
Measured: Baseline, Day 3, Day 5, Day 7
Cumulative incidence of new-onset organ failure at 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.
Measured: Up to Day 7
Correlation coefficients between serial immune-inflammatory marker changes and 28-day all-cause mortality
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.
Measured: Baseline, Day 1, Day 3, Day 5, up to Day 28
Proportion of participants with 28-day all-cause mortality
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.
Measured: Up to Day 28
Incidence of adverse events during treatment
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.
Measured: From the start of intervention to 4 weeks after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Complicated Intra-abdominal Infection (cIAI)Studies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel assignment design. Subjects are randomly divided into low-dose ulinastatin group, high-dose ulinastatin group and normal saline control group at a 1:1:1 ratio, all receiving standardized basic treatment simultaneously.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianqiang Chen, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672496
- Sponsor's protocol ID
- FJXH-2026-0506
- Acronym
- UTI-cIAI
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Chen L, Jin S, Yang M, Gui C, Yuan Y, Dong G, Zeng W, Zeng J, Hu G, Qiao L, Wang J, Xi Y, Sun J, Wang N, Wang M, Xing L, Yang Y, Teng Y, Hou J, Bi Q, Cai H, Zhang G, Hong Y, Zhang Z. Integrated Single Cell and Bulk RNA-Seq Analysis Revealed Immunomodulatory Effects of Ulinastatin in Sepsis: A Multicenter Cohort Study. Front Immunol. 2022 May 11;13:882774. doi: 10.3389/fimmu.2022.882774. eCollection 2022.
PubMed 35634310Karnad DR, Bhadade R, Verma PK, Moulick ND, Daga MK, Chafekar ND, Iyer S. Intravenous administration of ulinastatin (human urinary trypsin inhibitor) in severe sepsis: a multicenter randomized controlled study. Intensive Care Med. 2014 Jun;40(6):830-8. doi: 10.1007/s00134-014-3278-8. Epub 2014 Apr 16.
PubMed 24737258Lim YP, Bendelja K, Opal SM, Siryaporn E, Hixson DC, Palardy JE. Correlation between mortality and the levels of inter-alpha inhibitors in the plasma of patients with severe sepsis. J Infect Dis. 2003 Sep 15;188(6):919-26. doi: 10.1086/377642. Epub 2003 Aug 26.
PubMed 12964125Aziz MH, Sideras K, Aziz NA, Mauff K, Haen R, Roos D, Saida L, Suker M, van der Harst E, Mieog JS, Bonsing BA, Klaver Y, Koerkamp BG, van Eijck CH. The Systemic-immune-inflammation Index Independently Predicts Survival and Recurrence in Resectable Pancreatic Cancer and its Prognostic Value Depends on Bilirubin Levels: A Retrospective Multicenter Cohort Study. Ann Surg. 2019 Jul;270(1):139-146. doi: 10.1097/SLA.0000000000002660.
PubMed 29334554Feier CVI, Motoc A, Muntean C, Vonica RC, Gaborean V, Olariu S, Murariu MS. Systemic inflammatory indices and age-dependent severity in acute appendicitis: a retrospective cohort study. Front Immunol. 2025 Jul 15;16:1620459. doi: 10.3389/fimmu.2025.1620459. eCollection 2025.
PubMed 40735314Liu D, Huang SY, Sun JH, Zhang HC, Cai QL, Gao C, Li L, Cao J, Xu F, Zhou Y, Guan CX, Jin SW, Deng J, Fang XM, Jiang JX, Zeng L. Sepsis-induced immunosuppression: mechanisms, diagnosis and current treatment options. Mil Med Res. 2022 Oct 9;9(1):56. doi: 10.1186/s40779-022-00422-y.
PubMed 36209190Nebelung H, Wotschel N, Held HC, Kirchberg J, Weitz J, Radosa CG, Laniado M, Hoffmann RT, Plodeck V. ICU patients with infectious complications after abdominopelvic surgery: Is thoracic CT in addition to abdominal CT helpful? Ann Intensive Care. 2023 Feb 10;13(1):6. doi: 10.1186/s13613-023-01104-1.
PubMed 36763198Huston JM, Barie PS, Dellinger EP, Forrester JD, Duane TM, Tessier JM, Sawyer RG, Cainzos MA, Rasa K, Chipman JG, Kao LS, Pieracci FM, Colling KP, Heffernan DS, Lester J; Therapeutics and Guidelines Committee. The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update. Surg Infect (Larchmt). 2024 Aug;25(6):419-435. doi: 10.1089/sur.2024.137. Epub 2024 Jul 11.
PubMed 38990709
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07672496
- Acronym / sponsor ID
- UTI-cIAI / FJXH-2026-0506
- Conditions
- Complicated Intra-abdominal Infection (cIAI), Systemic Inflammatory Response, Sepsis, Immune Dysfunction
- Keywords
- immune dysfunction, Complicated intra-abdominal infection, Ulinastatin, SII, inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three-arm parallel assignment design. Subjects are randomly divided into low-dose ulinastatin group, high-dose ulinastatin group and normal saline control group at a 1:1:1 ratio, all receiving standardized basic treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Low-dose Ulinastatin | Experimental | Drug: ulinastatinIntravenous 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. |
| High-dose Ulinastatin | Experimental | Drug: ulinastatinIntravenous 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. |
| Normal Saline Placebo | Placebo comparator | Drug: Normal Saline (0.9% NaCl)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinLow dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline | Drug | High-dose Ulinastatin, Low-dose Ulinastatin |
| Normal Saline (0.9% NaCl)Equal-volume 0.9% normal saline iv tid×5d as placebo | Drug | Normal Saline Placebo |
Primary outcome
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5
Time frame: 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.
10 secondary outcomes
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at 48 Hours
Time frame: Baseline, 48 hours
Mean change from baseline in C-reactive protein (CRP) at Day 1, Day 3, Day 5
Time frame: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in Interleukin-6 (IL-6) at Day 1, Day 3, Day 5
Time frame: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+ T cell count at Day 1, Day 3, Day 5
Time frame: Baseline, Day 1, Day 3, Day 5
Mean change from baseline in CD4+/CD8+ T cell ratio at Day 1, Day 3, Day 5
Time frame: 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
Time frame: Baseline, Day 3, Day 5, Day 7
Cumulative incidence of new-onset organ failure at Day 7
Time frame: Up to Day 7
Correlation coefficients between serial immune-inflammatory marker changes and 28-day all-cause mortality
Time frame: Baseline, Day 1, Day 3, Day 5, up to Day 28
Proportion of participants with 28-day all-cause mortality
Time frame: Up to Day 28
Incidence of adverse events during treatment
Time frame: From the start of intervention to 4 weeks after the last study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 35634310Chen L, Jin S, Yang M, Gui C, Yuan Y, Dong G, Zeng W, Zeng J, Hu G, Qiao L, Wang J, Xi Y, Sun J, Wang N, Wang M, Xing L, Yang Y, Teng Y, Hou J, Bi Q, Cai H, Zhang G, Hong Y, Zhang Z. Integrated Single Cell and Bulk RNA-Seq Analysis Revealed Immunomodulatory Effects of Ulinastatin in Sepsis: A Multicenter Cohort Study. Front Immunol. 2022 May 11;13:882774. doi: 10.3389/fimmu.2022.882774. eCollection 2022.
- Background: PubMed 24737258Karnad DR, Bhadade R, Verma PK, Moulick ND, Daga MK, Chafekar ND, Iyer S. Intravenous administration of ulinastatin (human urinary trypsin inhibitor) in severe sepsis: a multicenter randomized controlled study. Intensive Care Med. 2014 Jun;40(6):830-8. doi: 10.1007/s00134-014-3278-8. Epub 2014 Apr 16.
- Background: PubMed 12964125Lim YP, Bendelja K, Opal SM, Siryaporn E, Hixson DC, Palardy JE. Correlation between mortality and the levels of inter-alpha inhibitors in the plasma of patients with severe sepsis. J Infect Dis. 2003 Sep 15;188(6):919-26. doi: 10.1086/377642. Epub 2003 Aug 26.
- Background: PubMed 29334554Aziz MH, Sideras K, Aziz NA, Mauff K, Haen R, Roos D, Saida L, Suker M, van der Harst E, Mieog JS, Bonsing BA, Klaver Y, Koerkamp BG, van Eijck CH. The Systemic-immune-inflammation Index Independently Predicts Survival and Recurrence in Resectable Pancreatic Cancer and its Prognostic Value Depends on Bilirubin Levels: A Retrospective Multicenter Cohort Study. Ann Surg. 2019 Jul;270(1):139-146. doi: 10.1097/SLA.0000000000002660.
- Background: PubMed 40735314Feier CVI, Motoc A, Muntean C, Vonica RC, Gaborean V, Olariu S, Murariu MS. Systemic inflammatory indices and age-dependent severity in acute appendicitis: a retrospective cohort study. Front Immunol. 2025 Jul 15;16:1620459. doi: 10.3389/fimmu.2025.1620459. eCollection 2025.
- Background: PubMed 36209190Liu D, Huang SY, Sun JH, Zhang HC, Cai QL, Gao C, Li L, Cao J, Xu F, Zhou Y, Guan CX, Jin SW, Deng J, Fang XM, Jiang JX, Zeng L. Sepsis-induced immunosuppression: mechanisms, diagnosis and current treatment options. Mil Med Res. 2022 Oct 9;9(1):56. doi: 10.1186/s40779-022-00422-y.
- Background: PubMed 36763198Nebelung H, Wotschel N, Held HC, Kirchberg J, Weitz J, Radosa CG, Laniado M, Hoffmann RT, Plodeck V. ICU patients with infectious complications after abdominopelvic surgery: Is thoracic CT in addition to abdominal CT helpful? Ann Intensive Care. 2023 Feb 10;13(1):6. doi: 10.1186/s13613-023-01104-1.
- Background: PubMed 38990709Huston JM, Barie PS, Dellinger EP, Forrester JD, Duane TM, Tessier JM, Sawyer RG, Cainzos MA, Rasa K, Chipman JG, Kao LS, Pieracci FM, Colling KP, Heffernan DS, Lester J; Therapeutics and Guidelines Committee. The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update. Surg Infect (Larchmt). 2024 Aug;25(6):419-435. doi: 10.1089/sur.2024.137. Epub 2024 Jul 11.
- Individual participant dataSharing planned: No. 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.
Related trials for Complicated Intra-abdominal Infection (cIAI)
RecruitingPhase 2
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Complicated Intra-abdominal Infections (cIAI)
RecruitingPhase 3
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Not yet recruitingPhase 3
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
Intra-abdominal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ulinastatin and Normal Saline (0.9% NaCl) in people with Complicated Intra-abdominal Infection (cIAI) and Systemic Inflammatory Response, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in Systemic Immune-Inflammation Index (SII) at Day 5 (time frame: Baseline (before treatment), Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672496, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.