[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04096014":3,"trial-entities:NCT04096014":96,"trial-summary:NCT04096014":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":14,"eligibility_criteria":47,"std_ages":64,"locations":67,"central_contacts":89,"overall_officials":93,"references":94,"see_also_links":95},"NCT04096014","18-749","Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy","RECRUITING","2026-10-30","2025-11","2025-11-25","2019-09-16","The Cleveland Clinic","OTHER",false,"Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.",null,[18],"Hepatic Encephalopathy",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Ensure Enlive","The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.",[30],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Standard Of Care","The subjects in the Standard of care group will continue to receive the standard clinical therapy.",[30,37],"Standard of Care",[39],{"measure":40,"description":41,"timeFrame":42},"Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.","Change in number of readmissions","Day 0 & Day 180",[],"ALL","18 Years","75 Years",{"inclusion":48,"exclusion":53,"raw_text":63},[49,50,51,52],"\\> 18 years of age","cirrhosis diagnosed by clinical history and liver biopsy and\u002For clinical, biochemical and imaging evidence of cirrhosis","at least 1 hospitalization for documented HE within the last 12 months.","abdominal CT scan anytime in the past",[54,55,56,57,58,59,60,61,62],"Patients with MELD score \\> 35","end stage organ failure (major dysfunction requiring organ support)","kidney injury defined by a creatinine \\> 2 mg\u002Fdl or rise in creatinine by 0.5 gm\u002Fdl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm\u002Fkg up to 100 gm\u002Fday)","active malignancy","uncontrolled diabetes mellitus with A1c\\>9.5 (to avoid altered muscle protein metabolism","medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass","recent gastrointestinal surgery within past 12 months","ongoing infection (positive blood or other body fluid cultures)","active gastrointestinal bleeding.","Inclusion Criteria:\n\n* \\> 18 years of age\n* cirrhosis diagnosed by clinical history and liver biopsy and\u002For clinical, biochemical and imaging evidence of cirrhosis\n* at least 1 hospitalization for documented HE within the last 12 months.\n* abdominal CT scan anytime in the past\n\nExclusion Criteria:\n\n* Patients with MELD score \\> 35\n* end stage organ failure (major dysfunction requiring organ support)\n* kidney injury defined by a creatinine \\> 2 mg\u002Fdl or rise in creatinine by 0.5 gm\u002Fdl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm\u002Fkg up to 100 gm\u002Fday)\n* active malignancy\n* uncontrolled diabetes mellitus with A1c\\>9.5 (to avoid altered muscle protein metabolism\n* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass\n* recent gastrointestinal surgery within past 12 months\n* ongoing infection (positive blood or other body fluid cultures)\n* active gastrointestinal bleeding.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":7,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":86},"Cleveland Clinic Foundation","Cleveland","Ohio","44195","United States",[75,80,83],{"name":76,"role":77,"phone":78,"email":79},"Annette Bellar, BS","CONTACT","216-445-6268","bellara@ccf.org",{"name":81,"role":77,"email":82},"Revathi Penumatsa","penumar@ccf.org",{"name":84,"role":85},"Srinivasan Dasarathy, MD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},41.4995,-81.69541,[90],{"name":91,"role":77,"phone":92,"phoneExt":92,"email":79},"Annette C Bellar","2166365247",[],[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98,18],"Cirrhosis",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a randomized study, meaning participants will be assigned by chance to either receive the Ensure Enlive supplement or standard care. It plans to include 40 participants.","completed","Protein Supplement for Hepatic Encephalopathy Readmissions","This study is looking at whether a protein supplement called Ensure Enlive can help reduce hospital readmissions for people with hepatic encephalopathy (a brain condition caused by liver disease). If you are between 18 and 75 years old, have cirrhosis (scarring of the liver), and have been hospitalized for hepatic encephalopathy at least once in the last year, you might be able to join. The study aims to see if taking Ensure Enlive twice a day for 180 days can lower readmission rates compared to standard care. The study plans to enroll 40 participants.","The study measures readmission rates at Day 0 and Day 180, indicating a follow-up period of 180 days.",94,"Participants in the intervention group will take two Ensure Enlive supplements per day for 180 days. The study will measure readmission rates at the beginning and end of this period.","Not stated in the trial record.",[30],"v2"]