[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465874":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":242,"collaborators":246,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":254,"sex":260,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":26,"studyType":266,"phases":267,"briefSummary":269,"conditions":270,"keywords":275,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},{"fullName":5,"class":6},"Jena University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TIPS group","EXPERIMENTAL","TIPS implant (transjugular intrahepatic portosystemic shunt)",[13],"Procedure: TIPS",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Standard medication therapy with terlipressin and albumin. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.",[19],"Drug: Standard of Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","TIPS","A transjugular intrahepatic portosystemic shunt (TIPS) is implanted into the cirrhotic liver",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Standard of Care","Terlipressin\u002FAlbumin treatment is the preferred standard of care treatment. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.",[15],[33],"Terlipressin + Albumin",[35],{"name":36,"affiliation":5,"role":37},"Cristina Ripoll, Prof. Dr.","STUDY_DIRECTOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+4936419","32 44 01","cristina.ripoll@med.uni-jena.de",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Alexander Zipprich, Prof. Dr.","alexander.zipprich@med.uni-jena.de",[48,65,78,93,105,118,130,145,160,172,184,199,214,227],{"facility":49,"status":50,"city":51,"state":26,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University Hospital RWTH Aachen","RECRUITING","Aachen","52074","Germany","DE",{"type":56,"coordinates":57},"Point",[58,59],6.08342,50.77664,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":26,"phoneExt":26,"email":64},"Tony Bruns, Prof. 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Großhadern","Munich","81377",{"type":56,"coordinates":219},[220,221],11.57549,48.13743,{"lat":221,"lon":220},[224],{"name":225,"role":40,"phone":26,"phoneExt":26,"email":226},"Christian Lange, Prof. Dr.","Christian.Lange@med.uni-muenchen.de",{"facility":228,"status":50,"city":229,"state":26,"zip":230,"country":53,"countryCode":54,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"University Hospital Münster, Medical Clinic B","Münster","48149",{"type":56,"coordinates":232},[233,234],7.62571,51.96236,{"lat":234,"lon":233},[237],{"name":238,"role":40,"phone":239,"phoneExt":240,"email":241},"Jonel Trebicka, Prof. Dr.","+49 251 83","57562","jonel.trebicka@ukmuenster.de",{"type":243,"investigatorFullName":244,"investigatorTitle":245,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Cristina Ripoll","Prof. Dr.",[247,249],{"name":248,"class":6},"German Research Foundation",{"name":250,"class":251},"University Hospital Halle (Saale)","UNKNOWN","100465874","hrs-aki-treatment-with-tips-in-patients-with-cirrhosis-100465874",false,"NCT05346393","HRS-AKI Treatment With TIPS in Patients With Cirrhosis","Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled Trial","Liver-HERO","Inclusion Criteria:\n\n1. Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and\u002For blood tests\n2. Clinically evident ascites due to portal hypertension\n3. HRS-AKI\n4. Age: ≥ 18 to ≤ 80 years old at the time of consent\n5. ECOG \\\u003C 4 prior to hospital admission\n6. Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.\n7. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective.\n\nExclusion Criteria:\n\n1. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI diagnosis\n2. Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr\u002Fkg\n3. Uncontrolled shock within the last 48 hours prior to randomization\n4. Patients with uncontrolled infection (defined by a 20 % increase in inflam-matory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid \\\u003C 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment.\n5. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (is-chemic cardiomyopathy, hypertensive cardiomyopathy, etc.)\n6. Patients with contraindications to TIPS placement (e.g. Bilirubin \\> 85.5 µmol\u002FL (≙ 5 mg\u002FdL), recurrent hepatic encephalopathy, clinically relevant pulmonary hypertension, aortic stenosis)\n7. Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis\n8. Patients with clinically significant cardiac disease (NYHA ≥ II)\n9. Patients with diastolic dysfunction grade 3.\n10. Patients with a reduced systolic function with an ejection fraction ≤ 50 %\n11. Patients with ACLF grade 3\n12. Patients with creatinine value \\> 442 µmol\u002FL (≙ 5 mg\u002FdL)\n13. Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and\u002For terlipressin.\n14. Patients with refractory ascites as defined by the International Ascites Club (\\\u003C 800 gr weight loss over 4 days in patients on low salt diet and high dose diuretics (spironolactone 400 mg \u002Fday and furosemide \\* 160 mg \u002Fday), or lower dose of diuretics with complications secondary to the use of diuretics such as hyponatremia, renal failure, hepatic encephalopathy. \\*equivalent dose of torasemide 40 mg\u002Fday\n15. Patients with hepatocellular carcinoma outside of the Milan criteria\n16. Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract.\n17. Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract.\n18. Patients who already have a TIPS placed\n19. Patients who already had a liver transplantation\n20. Patients with other comorbidities that lead to an estimated life expectancy under 1 year.\n21. Patients with respiratory insufficiency which requires mechanical ventila-tion\n22. Patients with circulatory failure which requires administration of other vas-opressors (catecholamines)\n23. Patients receiving renal replacement therapy\n24. The subject is currently enrolled in another investigational device or drug trial.\n25. Patients with pregnancy or lactation\n26. Patients which are suspected to be incompliant for study participation.","ALL","18 Years","80 Years",{"count":264,"type":265},124,"ESTIMATED","INTERVENTIONAL",[268],"NA","The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage1, 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).",[271,272,273,274],"Cirrhosis, Liver","Hepatorenal Syndrome","Acute Kidney Injury","Ascites Hepatic",[276,273,277,272,23,278,279],"Ascites","Cirrhosis","transjugular intrahepatic portosystemic shunt","Terlipressin","2024-11-14",{"date":282,"type":283},"2024-11-18","ACTUAL",{"date":285,"type":283},"2022-11-29",{"date":287,"type":265},"2026-06",{"name":5,"class":6},14]