[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343650":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":24,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":24,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Albumin","EXPERIMENTAL","All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.",[13,14],"Biological: Albumin","Other: Standard Medical Treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Medical Treatment","ACTIVE_COMPARATOR","Antibiotics, nutrition and supportive treatment.",[14],[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL",[9],null,{"type":6,"name":16,"description":26,"armGroupLabels":27,"otherNames":24},"Antibiotics, nutrition and supportive treatment",[9,16],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Dr Rakesh Jagdish, MD","CONTACT","01146300000","dr.rkj.kapil@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":24},"Institute of Liver & Biliary Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":44,"coordinates":45},"Point",[46,47],77.2148,28.62137,{"lat":47,"lon":46},{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100343650","efficacy-of-albumin-therapy-with-standard-medical-treatment-smt-as-compared-to-standard-medical-treatment-smt-in-improving-patient-survival-and-immune-modulation-in-patients-with-acute-on-chronic-liver-failure-asia-trial-100343650",false,"NCT03754400","Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).","A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).","Inclusion Criteria:\n\n1. Age \\>18 years to 65 years\n2. ACLF patients\n\nExclusion Criteria:\n\n1. Patients who have already received albumin in last 1 week\n2. Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)\n\n   ,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)\n3. Not given consent\n4. Significant cardiopulmonary or structural heart disease\u002F CKD(chronic kidney diseses) \u002Fvolume overload \u002Fupper GI bleed.\n5. Pregnant\u002F HIV \u002F HCC \\>2cm size\n6. Alcoholic hepatitis eligible for steroids\n7. Previous known allergic\u002Fadverse reaction to albumin\n8. Any clinical condition which the investigator considers would make the patient unsuitable for the trial\n9. Patients who will receive palliative treatment only during their hospital admission","ALL","18 Years","65 Years",{"count":62,"type":63},200,"ESTIMATED","INTERVENTIONAL",[66],"NA","The AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating\u002Fpreventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.\n\nAll ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS\u002Fsepsis in ACLF patients and possible beneficial factors for resolution of SIRS \u002Fsepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.",[69],"Acute on Chronic Liver Failure","UNKNOWN","2020-04-07",{"date":73,"type":74},"2020-04-08","ACTUAL",{"date":76,"type":74},"2018-09-10",{"date":78,"type":63},"2020-07-30",{"name":5,"class":6},1]