[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582297":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":19,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Universidad Autonoma de Nuevo Leon","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton Bomb Inhibitor","EXPERIMENTAL","These patients are to receive omeprazole or pantoprazole after randomization.",[13,14],"Drug: Omeprazole 40 mg IV","Drug: pantoprazole 40 mg iv",{"label":16,"type":17,"description":18,"interventionNames":19},"No Proton Bomb Inhibitor","NO_INTERVENTION","These patients are not to receive omeprazol after randomization.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DRUG","Omeprazole 40 mg IV","Daily until discharge",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"pantoprazole 40 mg iv","Daily until discharge if omeprazole is unavailable.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":19,"email":35},"Luis A González Torres, MD","CONTACT","+5218116091332","Luis37torres@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":19},"Hospital Universitario \"Jose E. González\" de la Facultad de Medicina, Universidad Autónoma de Nuevo León","RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":46,"coordinates":47},"Point",[48,49],-100.31721,25.68435,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Luis Andrés González Torres","Resident","100582297","phase-2-ppis-and-in-hospital-morbidity-in-acute-variceal-bleeding-with-chronic-liver-disease-100582297",false,"NCT06861478","PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease","In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment","Liver-IMPACT","Inclusion Criteria\n\n* Adult\n* Cirrhosis\n* Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications\n* Hypovolemic shock and Variceal bleeding\n\nExclusion Criteria:\n\n* Shock of any type other than hypovolemic.\n* No cirrhotic patients\n* Patients that have severe Hepatic Encephalopathy at admission (West Haven 3 and 4)\n* Hepatorenal syndrome\n* Acute on chronic with CLIF-C \\>50 points\n* Septic patients\n* Spontaneous Bacterial Peritonitis\n\nElimination Criteria\n\n* Voluntary removal of the study\n* Violation of the study protocol\n* Patients in the no PBI group that need prolonged mecánica ventilación.","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","With this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (PLC) who present to the emergency department with variceal bleeding (VB).\n\nThis study is a longitudinal, prospective, experimental, analytical single-center clinical trial. The study will be performed in the Hospital Universitario \"Jose E. González\" de la Factultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.\n\nThe studied population consists of adult-age patients with previous, recent, or new diagnoses of cirrhosis who present to the ED with VH without shock, infection, or acute or chronic disease with a \\\u003C30% probability of death (CLIF-C \\\u003C50). The exclusion criteria involve minor age, Acute Liver Failure (ALF), ICU patients, Hepatorenal Syndrome, sepsis or infection, and shock on admission except for hypovolemic and CLIF-C \\>50 points. Elimination criteria involve patients who want to discontinue treatment and patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers, duodenal ulcers, bleeding GAVE, and atrophic gastritis).\n\nAfter the endoscopic intervention, the investigators will propose inclusion. After acceptance with Informed Consent, the investigators will randomize the patients to receive or not receive Omeprazole\u002F Pantoprazole 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy grades III and IV, intra-hospital infections, re-bleeding, shock, and acute kidney failure.\n\nThe secondary outcomes include the individual analysis of each component of our compound primary outcome, mortality by day 30, differences when grouping patients by Child-Pugh stratification, and comparing results in patients receiving omeprazole for more or less than 5 days.",[73],"Morbidity",[75,73,76],"Variceal Bleeding","Proton Pump Inhibitors","2026-06-10",{"date":79,"type":80},"2026-06-12","ACTUAL",{"date":82,"type":80},"2024-10-20",{"date":84,"type":67},"2026-09-20",{"name":5,"class":6},1]