[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642920":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutrition Intervention 1","EXPERIMENTAL","As participants are blinded, description of the arm is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.",[13],"Dietary Supplement: High Energy and High Protein Diet 1",{"label":15,"type":16,"description":11,"interventionNames":17},"Nutrition Intervention 2","ACTIVE_COMPARATOR",[18],"Dietary Supplement: High Energy and High Protein Diet 2",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","High Energy and High Protein Diet 1","As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"High Energy and High Protein Diet 2",[15],[30],{"name":31,"affiliation":32,"role":33},"Amine Benmassaoud, MD","Research Institute of the McGill University Health Centre","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Nassim Oumansour, BSc","CONTACT","514-934-1934","34868","nassim.oumansour@rimuhc.ca",[42],{"facility":43,"status":25,"city":44,"state":45,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"McGill University Health Centre","Montreal","Quebec","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-73.58781,45.50884,{"lat":52,"lon":51},[55],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":40},{"type":33,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Amine Benmassaoud","Principal Investigator",[60],{"name":61,"class":62},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100642920","personalized-nutritional-intervention-in-patients-undergoing-tips-insertion-for-refractory-ascites-to-prevent-overt-hepatic-encephalopathy-100642920",false,"NCT07634237","Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy","Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)","SUPPRESS-HE","Inclusion Criteria:\n\n* Diagnosis of cirrhosis\n* TIPS planned for refractory ascites\n* Being at least moderately malnourished\n\nExclusion Criteria:\n\n* TIPS insertion for other reason than refractory ascites\n* Budd Chiari Syndrome\n* Complete or cavernomatous portal vein thrombosis\n* Pre-TIPS recurrent or persistent overt hepatic encephalopathy\n* Use of lactulose or rifaximin in the last 4 weeks\n* Liver failure (MELD \\> 18 or Child Pugh score \\> 12)\n* Heart failure (NYHA ≥ III or LVEF \\\u003C 50%)\n* Kidney failure (serum creatinine \\> 250µmol\u002FL)\n* Pregnancy or breastfeeding\n* Previous Liver transplantation\n* Unable to provide informed consent","ALL","18 Years","70 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.",[82,83,84],"Cirrhosis","Refractory Ascites","TIPS Insertion",[86,87,82,83,84],"Personalized Nutritional Intervention","Overt Hepatic Encephalopathy","NOT_YET_RECRUITING","2026-06-03",{"date":91,"type":92},"2026-06-08","ACTUAL",{"date":94,"type":76},"2026-06-15",{"date":96,"type":76},"2029-12-15",{"name":5,"class":6},1]