[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612347":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":39,"armGroups":48,"interventions":61,"overallOfficials":75,"centralContacts":84,"locations":92,"responsibleParty":108,"collaborators":39,"id":111,"slug":39,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":39,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":39,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":135,"whyStopped":39,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"General Hospital of Shenyang Military Region","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Reversal of AKI","The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.","5 days",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Duration of AKI","The duration of AKI is defined as the time from occurrence to reversal of AKI.","6 weeks",{"measure":19,"description":20,"timeFrame":17},"Recurrence of AKI","Clinical symptoms related to AKI recur and SCr levels increase after the reserval of AKI. The diagnosis of AKI should meet any of the following conditions: an increase in SCr level of ≥0.3 mg\u002Fdl (26.5 μmol\u002FL) within 48 hours; or an increase in SCr level to ≥1.5 times the baseline value within 7 days; or urine output \\\u003C0.5 ml\u002Fkg per hour for a continuous 6 hours.",{"measure":22,"description":23,"timeFrame":17},"Kidney replacement therapy rate","Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.",{"measure":25,"description":26,"timeFrame":17},"Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate","Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.",{"measure":28,"description":29,"timeFrame":17},"Liver and kidney transplantation treatment rate","Participants undergo liver and kidney transplantation treatment.",{"measure":31,"description":32,"timeFrame":17},"6-week mortality rate","The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.",{"measure":34,"description":35,"timeFrame":17},"6-week rebleeding rate","The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.",{"measure":37,"description":38,"timeFrame":17},"Adverse events","Adverse events will be monitored, including nausea, abdominal pain, diarrhea, arrhythmia, dyspnea, and hyponatremia that may be caused by terlipressin, as well as nausea, abdominal pain, diarrhea, hypoglycemia, and allergies that may be caused by somatostatin.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Parallel Assignment","TREATMENT",{"masking":46,"maskingDescription":39,"whoMasked":39},"NONE","Overall, 64 cirrhotic patients with a diagnosis of AGIB and AKI will be enrolled. They will be stratified according to the severity of AKI, and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary endpoint is reversal of AKI after treatment on 5 days. Secondary endpoints include duration of AKI, recurrence of AKI, rates of renal replacement therapy, transjugular intrahepatic portosystemic shunt (TIPS) treatment, liver, and kidney transplantation, 6-week mortality, 6-week rebleeding rate, and incidence of adverse events.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Terlipressin group","EXPERIMENTAL","Continuous intravenous infusion of terlipressin 2-4 mg every 12 hours.",[54],"Drug: 2-4 mg of terlipressin",{"label":56,"type":57,"description":58,"interventionNames":59},"Somatostatin group","ACTIVE_COMPARATOR","Continuous intravenous infusion of somatostatin 3 mg every 12 hours.",[60],"Drug: 3 mg of somatostatin",[62,69],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"DRUG","2-4 mg of terlipressin","Participants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.",[50],[68],"Terlivaz",{"type":63,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"3 mg of somatostatin","Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.",[56],[74],"Stilamin",[76,80,82],{"name":77,"affiliation":78,"role":79},"Xingshun Qi, MD","Department of Gastroenterology, General Hospital of Northern Theater Command","PRINCIPAL_INVESTIGATOR",{"name":81,"affiliation":78,"role":79},"Qianqian Li",{"name":83,"affiliation":78,"role":79},"Rong Li",[85,89],{"name":77,"role":86,"phone":87,"phoneExt":39,"email":88},"CONTACT","18909881019","xingshunqi@126.com",{"name":81,"role":86,"phone":90,"phoneExt":39,"email":91},"13940307473","1208594776@qq.com",[93],{"facility":94,"status":39,"city":95,"state":96,"zip":39,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)","Shenyang","Liaoning","China","CN",{"type":100,"coordinates":101},"Point",[102,103],123.43278,41.79222,{"lat":103,"lon":102},[106,107],{"name":77,"role":86,"phone":87,"phoneExt":39,"email":88},{"name":81,"role":86,"phone":90,"phoneExt":39,"email":91},{"type":79,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Xingshun Qi","Director of Department of Gastroenterology","100612347",false,"NCT07252401","Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury","Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* patients have a definite diagnosis of live cirrhosis and AKI;\n* patients present with AGIB at admission;\n* patients' age 18-70 years old;\n* patients or relatives can sign the informed consent form.\n\nExclusion Criteria:\n\n* patients have hepatorenal syndrome- acute renal injury (HRS-AKI);\n* patients have structural kidney injury;\n* patients have chronic kidney disease;\n* patients received terlipressin or somatostatin therapy within 48 hours before enrollment;\n* patients received kidney replacement therapy before enrollment;\n* patients have a history of liver transplantation or TIPS;\n* patients have acute liver failure or acute-on-chronic liver failure;\n* patients have hepatic or renal malignant tumor;\n* patients have severe diseases of the heart, lungs, and brain;\n* patients have contraindications for experimental drugs;\n* patients are in pregnancy or lactation;\n* patients participated in other clinical studies within 3 months before enrollment;\n* patients have other conditions that investigators deem unsuitable for enrollment in the study.","ALL","18 Years","70 Years",{"count":121,"type":122},64,"ESTIMATED","INTERVENTIONAL",[125],"NA","Acute gastrointestinal bleeding (AGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Existing evidence suggests that both terlipressin and somatostatin can be used to control AVB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AGIB complicated by acute kidney injury (AKI). Herein, a multicenter randomized controlled trial (RCT) has been designed to compare the efficacy of terlipressin and somatostatin in the treatment of cirrhotic patients with AGIB complicated by AKI.",[128],"Liver Cirrhosis",[130,131,132,133,134],"acute gastrointestinal bleeding","acute kidney injury","terlipressin","somatostatin","liver cirrhosis","NOT_YET_RECRUITING","2025-11-19",{"date":138,"type":139},"2025-11-26","ACTUAL",{"date":141,"type":122},"2025-12-25",{"date":143,"type":122},"2028-03-31",{"name":5,"class":6},1]