[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644724":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":35,"responsibleParty":60,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":30,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":91,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fujian Medical University Union Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: ulinastatin",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"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.",[23],"Drug: Normal Saline (0.9% NaCl)",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","ulinastatin","Low dose:100000 IU iv tid×5d; High dose:300000 IU iv tid×5d, diluted in 100mL normal saline",[15,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Normal Saline (0.9% NaCl)","Equal-volume 0.9% normal saline iv tid×5d as placebo",[19],[36],{"facility":5,"status":30,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fuzhou","Fujian","350001","China","CN",{"type":43,"coordinates":44},"Point",[45,46],119.30611,26.06139,{"lat":46,"lon":45},[49,54,57],{"name":50,"role":51,"phone":52,"phoneExt":30,"email":53},"JunRong Zhang, MD","CONTACT","0591-83357896","foxbaby34@163.com",{"name":55,"role":56,"phone":30,"phoneExt":30,"email":30},"QinYong Weng, MD","PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":30,"phoneExt":30,"email":30},"XianQiang Chen, MD","SUB_INVESTIGATOR",{"type":56,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Xianqiang Chen","Chief Physician","100644724","ulinastatin-on-systemic-immune-inflammation-in-patients-with-complicated-intra-abdominal-infection-100644724",false,"NCT07672496","Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection","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","UTI-cIAI","Inclusion Criteria:\n\n1. Able to provide written informed consent voluntarily.\n2. Age ≥ 18 years old, any gender.\n3. 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\u002Fultrasound\u002FMRI), intraoperative findings, or positive pathogen culture of abdominal drainage fluid.\n4. Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points.\n\nExclusion Criteria:\n\n1. Severe immune deficiency conditions, including AIDS, prior solid organ or bone marrow transplantation, HIV infection with CD4 count \\\u003C 200 cells\u002Fmm³, long-term high-dose glucocorticoid therapy (prednisone \\> 20 mg\u002Fday), ongoing chemotherapy for malignant tumors, or absolute neutrophil count \\\u003C 1000 cells\u002Fmm³.\n2. 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.\n3. Patients with active malignant tumors, pregnancy, or severe psychiatric disorders.\n4. American Society of Anesthesiologists (ASA) physical status grade IV or above.\n5. Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points.\n6. Critically ill patients with expected death within 48 hours after admission.\n7. Known allergy to ulinastatin or any ingredients of the study preparation.\n8. Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.","ALL","18 Years",{"count":74,"type":75},165,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82,83,84],"Complicated Intra-abdominal Infection (cIAI)","Systemic Inflammatory Response","Sepsis","Immune Dysfunction",[86,87,88,89,90],"immune dysfunction","Complicated intra-abdominal infection","Ulinastatin","SII","inflammation","NOT_YET_RECRUITING","2026-06-26",{"date":94,"type":95},"2026-06-29","ACTUAL",{"date":97,"type":75},"2026-10-30",{"date":99,"type":75},"2028-06-30",{"name":5,"class":6},1]