[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578522":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":12,"centralContacts":30,"locations":40,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":12,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"VA Connecticut Healthcare System","FED",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Albumin first","ACTIVE_COMPARATOR","Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Placebo first","PLACEBO_COMPARATOR","Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.",[18,19],"Drug: Albumin infusion (25% albumin)","Drug: Normal Saline (0.9% NaCl)",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"DRUG","Albumin infusion (25% albumin)","Albumin 25 gram infusion",[14],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"Normal Saline (0.9% NaCl)","100 cc of normal saline",[14],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Anahita Rabiee, MD, MHS","CONTACT","203-932-5711","ext.1-5871","anahita.rabiee@va.gov",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},"Lynn F. Buchwalder, M.S.","Lynn.Buchwalder@va.gov",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"West Haven VA Medical Center","RECRUITING","West Haven","Connecticut","06516","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-72.94705,41.27065,{"lat":53,"lon":52},[56,57],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},{"name":58,"role":33,"phone":34,"phoneExt":12,"email":39},"Lynn F Buchwalder, M.S.",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Anahita Rabiee MD MHS","Staff Hepatologist, MD, MHS",[64],{"name":65,"class":66},"Grifols Shared Services North America, Inc.","INDUSTRY","100578522","phase-2-albumin-assisted-diuresis-in-patients-with-cirrhosis-and-ascites-100578522",false,"NCT06812390","Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites","Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial","Inclusion Criteria:\n\n* Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration\n* Serum albumin of \\\u003C 3.5 g\u002FdL\n* Age \\>=18 years old\n\nExclusion Criteria:\n\n* Patients with GFR \\\u003C 30mL\u002Fmin\u002F1.73 m2\n* Changes in oral diuretic regimen in the past 7 days (\\*\\*patients can enter the study after 7 days of the change)\n* Large Volume paracentesis (LVP) in the past 7 days (\\*\\*patients can enter the study after 7 days)\n* Albumin infusion within the previous 14 days (\\*\\* patients can enter the study after 14 days)\n* Spontaneous Bacterial Peritonitis in the past month\n* Active variceal bleeding\n* Current Hepatic encephalopathy (\\>= Grade 2 based on West Haven criteria)\n* Co-administration of other diuretics such as Hydrochlorothiazide (amiloride or eplerenone in place of spironolactone, and Bumex\u002FTorsemide in place of furosemide are acceptable)\n* Hypotension (Mean Arterial Pressure \\\u003C65 mmHg, Systolic Blood pressure \\\u003C90 mmHg)\n* Severe hyponatremia (Sodium \\\u003C125 mEq\u002FL)\n* previous diagnosis of overt heart failure (systolic EF \\\u003C 50%)\n* Baseline oxygen requirement\n* Hypersensitivity to albumin preparations","ALL","18 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.",[84,85],"Cirrhosis","Ascites Hepatic",[87,88,89,90],"albumin","cirrhosis","ascites","diuresis","2025-03-10",{"date":93,"type":94},"2025-03-11","ACTUAL",{"date":96,"type":94},"2025-02-28",{"date":98,"type":78},"2027-03",{"name":61,"class":6},1]