[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatorenal-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatorenal-syndrome":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,38,64,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100523419","a-retrospective-analysis-of-outcomes-in-patients-with-hepatorenal-syndrome-at-methodist-dallas-medical-center-100523419",false,"NCT06095440","A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center","Inclusion Criteria:\n\n* All patients \\>18 years old that were hospitalized between April 1st 2019 and April 1st 2023 who either presented with HRS-AKI or developed a diagnosis of HRS during the hospital course. HRS-AKI will be defined based on the ICA criteria, described below:\n\n  1. Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure\n  2. An increase in serum Cr of ≥0.3 mg\u002FdL within 48 hours or ≥50% from baseline value and\u002For urinary output ≤0.5 mL\u002Fkg of body weight for ≥6 hours (requires use of a urinary catheter)\n  3. No full or partial response for ≥2 days of diuretic withdrawal and volume expansion with albumin (dosed at 1 g\u002Fkg of body weight\u002Fday)\n  4. Absence of shock\n  5. No current or recent treatment with nephrotoxic drugs\n  6. Absence of parenchymal renal disease\n  7. Suggestion of renal vasoconstriction based on FENa \\\u003C0.2%\n\nExclusion Criteria:\n\n* 1\\. HRS-AKI patients \\\u003C18 years of age 2. All patients hospitalized between April 1st 2019 and April 1st 2023 without a diagnosis of HRS-AKI.","ALL","18 Years","85 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in patients with liver disease \\[1\\]. Increased activity and presence of vasodilators such as nitric oxide in cirrhotic patients leads to vasodilation, especially in the splanchnic circulation, resulting in hemodynamic changes that precipitate renal injury \\[1\\]. Patients may present with elevated serum creatinine (Cr), benign urine sediment, and low urine sodium \\[1\\].",[24],"Hepatorenal Syndrome","RECRUITING","2026-04-27",{"date":28,"type":29},"2026-05-01","ACTUAL",{"date":31,"type":29},"2023-05-13",{"date":33,"type":20},"2027-05-13",{"name":35,"class":36},"Methodist Health System","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":37},"100556478","initial-resuscitation-for-acute-kidney-injury-in-cirrhosis-100556478","NCT06525623","Initial Resuscitation for Acute Kidney Injury in Cirrhosis","Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm","RAKI-VAGA","Inclusion Criteria:\n\n1. Adult age 18 years or greater\n2. Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.\n3. Admitted to the hospital\n4. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).\n5. Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg\u002FdL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.\n\nExclusion Criteria:\n\n1. Requiring \\>2 liters (L) supplemental oxygen at the time of screening.\n2. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).\n3. Allergy or other contraindication to IV albumin administration.\n4. Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.\n5. Patient and\u002For legally authorized representative unable to provide informed consent.\n6. Hepatic encephalopathy grade 3 or 4 at the time of screening.\n7. Already received \\>200 g albumin during admission at the time of screening.\n8. Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.\n9. Admission to the intensive care unit at the time of screening.\n10. Mechanical ventilation at the time of screening.\n11. Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.\n12. History of prior liver or kidney transplant.\n13. Pregnant or nursing status\n14. Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.",{"count":47,"type":20},50,"INTERVENTIONAL",[50],"NA","The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?\n\nPatients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.",[53,54,24],"Cirrhosis, Liver","Acute Kidney Injury","2026-03-11",{"date":57,"type":29},"2026-03-13",{"date":59,"type":29},"2024-09-12",{"date":61,"type":20},"2027-05-01",{"name":63,"class":36},"Massachusetts General Hospital",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":37},"100242450","use-of-novel-plasma-and-urinary-biomarkers-to-predict-the-development-of-hepatorenal-syndrome-in-cirrhotic-patients-100242450","NCT02434445","Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients","Inclusion Criteria:\n\n* Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Patients with co-existing renal diseases","90 Years",{"count":72,"type":20},100,"This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.",[24],"2024-12-13",{"date":77,"type":29},"2024-12-16",{"date":79,"type":29},"2012-06-01",{"date":81,"type":20},"2028-12-31",{"name":83,"class":36},"The University of Hong Kong",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":48,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100465874","hrs-aki-treatment-with-tips-in-patients-with-cirrhosis-100465874","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.","80 Years",{"count":94,"type":20},124,[50],"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).",[53,24,54,98],"Ascites Hepatic",[100,54,101,24,102,103,104],"Ascites","Cirrhosis","TIPS","transjugular intrahepatic portosystemic shunt","Terlipressin","2024-11-14",{"date":107,"type":29},"2024-11-18",{"date":109,"type":29},"2022-11-29",{"date":111,"type":20},"2026-06",{"name":113,"class":36},"Jena University Hospital",14]