[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578185":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":27,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":27,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"lactulose and rifaximin","EXPERIMENTAL","T. Rifaximin 550 mg po bd Syp Lactulose to ensure 2-3 motions",[13,14],"Drug: Lactulose","Drug: Rifaximin",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Medical Treatment","ACTIVE_COMPARATOR","Routine medicines, Albumin Iv antibiotics,Protein powder , branched chain amino acids",[20],"Other: Standard Medical treatment",[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Lactulose","Syp lactulose",[9],null,{"type":23,"name":29,"description":29,"armGroupLabels":30,"otherNames":27},"Rifaximin",[9],{"type":6,"name":32,"description":32,"armGroupLabels":33,"otherNames":27},"Standard Medical treatment",[16],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":27,"email":39},"Dr Shreya Singh, MD","CONTACT","01146300000","shreyasingh2746@gmail.com",{"name":41,"role":37,"phone":38,"phoneExt":27,"email":42},"Dr Ankur Jindal, DM","ankur.jindal3@gmail.com",[44],{"facility":45,"status":27,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Institute of Liver & Biliary Sciences (ILBS)","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":52,"coordinates":53},"Point",[54,55],77.2148,28.62137,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":38,"phoneExt":27,"email":39},{"type":60,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100578185","goal-directed-ammonia-lowering-therapy-in-hyperammonemic-aclf-patients-with-no-overt-he-to-reduce-major-adverse-liver-related-outcomes-goal-trial-100578185",false,"NCT06808009","Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)","Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)- A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18-70 years\n2. ACLF as per APASL criteria (AARC grade I\u002FII)\n3. Baseline ammonia levels of ≥135ug\u002Fdl or 79.5umol\u002Fl\n4. Given informed consent\n\nExclusion Criteria:\n\n* 1\\. Overt HE 2. AARC grade III 3. Confirmed or suspected bacterial infection 4. Extrahepatic organ failure 5. Renal dysfunction lasting for more than 48 hours or need for vasoconstrictors 6. Paralytic ileus 7. Patients with hepatocellular carcinoma beyond Milan criteria or any other neoplastic disorder 8. Pregnant and lactating women 9. Use of lactulose, rifaximin or LOLA in past 48h 10. Uncontrolled DM, HT, CAD 11. Patients with allergy or other contraindications of the used drugs","ALL","18 Years","70 Years",{"count":72,"type":73},90,"ESTIMATED","INTERVENTIONAL",[76],"NA","SIRS in ACLF exacerbate adverse effects of ammonia - sarcopenia, infections, immune dysfunction, HE and organ dysfunction Persistent or incident hyperammonemia during first week of hospitalization in patients with ACLF is associated with increased risk of organ failure and death. Prospective studies on the efficacy of ammonia lowering therapies on major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE are limited. In this study we aim to to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.",[79],"Acute on Chronic Liver Failure","NOT_YET_RECRUITING","2025-02-03",{"date":83,"type":84},"2025-02-04","ACTUAL",{"date":86,"type":73},"2025-02-05",{"date":88,"type":73},"2026-02-28",{"name":5,"class":6},1]