[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416686":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":243,"collaborators":246,"id":261,"slug":262,"hasResults":263,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":263,"sex":269,"minAge":270,"maxAge":26,"enrollmentInfo":271,"targetDuration":26,"studyType":274,"phases":275,"briefSummary":277,"conditions":278,"keywords":283,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"20-25% Albumin fluid","ACTIVE_COMPARATOR","100 mL 20-25% Albumin fluid at the initiation of continuous renal replacement therapy (CRRT), prolonged intermittent renal replacement therapy (PIRRT), or intermittent hemodialysis (IHD) and another 100 mL 20-25% Albumin fluid and halfway through RRT sessions in ICU.",[13],"Biological: 20-25% Albumin fluid (100 mL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal Saline","PLACEBO_COMPARATOR","100 mL at the initiation of CRRT, SLED or IHD and another 100 mL 0.9% Normal Saline halfway through RRT sessions in ICU.",[19],"Other: 0.9% Normal Saline (100 mL)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","20-25% Albumin fluid (100 mL)","Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU.\n\nRRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"0.9% Normal Saline (100 mL)","Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU.\n\nRRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting\u002Frandomization then every 12 hours while continuing on CRRT).",[15],[32],{"name":33,"affiliation":5,"role":34},"Edward G Clark, MD MSc FRCPC","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","613-737-8899","82569","edclark@toh.ca",{"name":42,"role":37,"phone":43,"phoneExt":26,"email":44},"Irene Watpool, RN BScN","613-737-8724","iwatpool@ohri.ca",[46,62,74,86,99,112,119,135,148,159,172,185,194,207,220,231],{"facility":47,"status":48,"city":49,"state":50,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Governors of the University of Calgary","NOT_YET_RECRUITING","Calgary","Alberta","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-114.08529,51.05011,{"lat":57,"lon":56},[60],{"name":61,"role":34,"phone":26,"phoneExt":26,"email":26},"Daniel Niven, MD",{"facility":63,"status":48,"city":64,"state":65,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of Manitoba - Health Sciences Centre","Winnipeg","Manitoba",{"type":54,"coordinates":67},[68,69],-97.14704,49.8844,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":26,"phoneExt":26,"email":26},"Ryan Zarychanski, MD",{"facility":75,"status":48,"city":76,"state":77,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Nova Scotia Health Authority","Halifax","Nova Scotia",{"type":54,"coordinates":79},[80,81],-63.57688,44.64269,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":26,"phoneExt":26,"email":26},"Volker Eichhorn, MD",{"facility":87,"status":88,"city":89,"state":90,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hamilton Health Sciences Corporation","RECRUITING","Hamilton","Ontario",{"type":54,"coordinates":92},[93,94],-79.84963,43.25011,{"lat":94,"lon":93},[97],{"name":98,"role":34,"phone":26,"phoneExt":26,"email":26},"Emilie Belley-Côté, MD",{"facility":100,"status":88,"city":101,"state":90,"zip":102,"country":51,"countryCode":52,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Kingston General Hospital","Kingston","K7L 2V7",{"type":54,"coordinates":104},[105,106],-76.48098,44.22976,{"lat":106,"lon":105},[109,111],{"name":110,"role":37,"phone":26,"phoneExt":26,"email":26},"Samuel A Silver, MD MSc FRCPC",{"name":110,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":113,"status":88,"city":114,"state":90,"zip":115,"country":51,"countryCode":52,"cosmosGeoPoint":26,"geoPoint":26,"contacts":116},"Sunnybrook Health Sciences Centre","North York","M4N 3M5",[117],{"name":118,"role":34,"phone":26,"phoneExt":26,"email":26},"Neill Adhikari, MD",{"facility":120,"status":88,"city":121,"state":90,"zip":122,"country":51,"countryCode":52,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"The Ottawa Hospital","Ottawa","K1H 8L6",{"type":54,"coordinates":124},[125,126],-75.69812,45.41117,{"lat":126,"lon":125},[129,130,134],{"name":42,"role":37,"phone":43,"phoneExt":26,"email":44},{"name":131,"role":37,"phone":38,"phoneExt":132,"email":133},"Heather Langlois, BSc","72998","hlanglois@ohri.ca",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":136,"status":88,"city":121,"state":90,"zip":137,"country":51,"countryCode":52,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"University of Ottawa Heart Institute","K1Y 4W7",{"type":54,"coordinates":139},[125,126],{"lat":126,"lon":125},[142,144,145],{"name":143,"role":37,"phone":26,"phoneExt":26,"email":26},"Rebecca Mathew, MD FRCPC",{"name":143,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":146,"role":147,"phone":26,"phoneExt":26,"email":26},"Bernard McDonald, PhD MD FRCPC","SUB_INVESTIGATOR",{"facility":149,"status":48,"city":150,"state":90,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Scarborough Health Network","Scarborough Village",{"type":54,"coordinates":152},[153,154],-79.22124,43.73899,{"lat":154,"lon":153},[157],{"name":158,"role":34,"phone":26,"phoneExt":26,"email":26},"Chris Yarnell, MD",{"facility":160,"status":88,"city":161,"state":90,"zip":162,"country":51,"countryCode":52,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Niagara Health System","St. Catharines","L2S0A9",{"type":54,"coordinates":164},[165,166],-79.24267,43.17126,{"lat":166,"lon":165},[169,171],{"name":170,"role":37,"phone":26,"phoneExt":26,"email":26},"Jennifer Tsang, MD, PhD",{"name":170,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":173,"status":48,"city":174,"state":90,"zip":175,"country":51,"countryCode":52,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"St. Michael's Hospital","Toronto","M5B 1W8",{"type":54,"coordinates":177},[178,179],-79.39864,43.70643,{"lat":179,"lon":178},[182,184],{"name":183,"role":37,"phone":26,"phoneExt":26,"email":26},"Ron Wald, MDCM MPH",{"name":183,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":186,"status":88,"city":174,"state":90,"zip":187,"country":51,"countryCode":52,"cosmosGeoPoint":188,"geoPoint":190,"contacts":191},"Sinai Health System","M5G1X5",{"type":54,"coordinates":189},[178,179],{"lat":179,"lon":178},[192],{"name":193,"role":34,"phone":26,"phoneExt":26,"email":26},"Sangeeta Mehta, MD",{"facility":195,"status":48,"city":196,"state":90,"zip":197,"country":51,"countryCode":52,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Lakeridge Health","Whitby","L1N 6K9",{"type":54,"coordinates":199},[200,201],-78.93287,43.88342,{"lat":201,"lon":200},[204,206],{"name":205,"role":37,"phone":26,"phoneExt":26,"email":26},"Shannon Fernando, MD",{"name":205,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":208,"status":88,"city":209,"state":210,"zip":211,"country":51,"countryCode":52,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Centre Integre de Sante et de Services Sociaux de Laval","Laval","Quebec","H7M3L9",{"type":54,"coordinates":213},[214,215],-73.692,45.56995,{"lat":215,"lon":214},[218],{"name":219,"role":34,"phone":26,"phoneExt":26,"email":26},"Marios Roussos, MD",{"facility":221,"status":88,"city":222,"state":210,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke","Sherbrooke",{"type":54,"coordinates":224},[225,226],-71.89908,45.40008,{"lat":226,"lon":225},[229],{"name":230,"role":34,"phone":26,"phoneExt":26,"email":26},"François Lamontagne, MD",{"facility":232,"status":48,"city":233,"state":234,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"University of Saskatchewan","Saskatoon","Saskatchewan",{"type":54,"coordinates":236},[237,238],-106.66892,52.13238,{"lat":238,"lon":237},[241],{"name":242,"role":34,"phone":26,"phoneExt":26,"email":26},"Sabira Valiani, MD",{"type":34,"investigatorFullName":244,"investigatorTitle":245,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Edward Clark","Principal Investigator",[247,249,251,254,257,259],{"name":248,"class":6},"The Physicians' Services Incorporated Foundation",{"name":250,"class":6},"The Kidney Foundation of Canada",{"name":252,"class":253},"The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.","UNKNOWN",{"name":255,"class":256},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":258,"class":6},"Canadian Blood Services",{"name":260,"class":6},"Héma-Québec","100416686","phase-4-albumin-to-enhance-recovery-after-acute-kidney-injury-100416686",false,"NCT04705896","Albumin To Enhance Recovery After Acute Kidney Injury","Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial","ALTER-AKI","Inclusion Criteria:\n\n* Age ≥18 years old;\n* Admission to a critical care unit\u002Fintensive care unit (ICU) for \\> 24 hours;\n* Receiving vasoactive therapy AND\u002FOR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));\n* Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT during their ICU admission;\n\nExclusion Criteria:\n\n* Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;\n* Known pre-hospitalization end-stage kidney disease;\n* Kidney transplant within the past 365 days;\n* Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;\n* Advanced cirrhosis (Child Pugh class C \\[score 10-15\\]), spontaneous bacterial peritonitis or hepatorenal syndrome;\n* Acute peritoneal dialysis used as the initial RRT modality;\n* Contraindications to albumin:\n\n  1. Admitted with traumatic brain injury\n  2. Increased intra-cranial pressure in those with intra-cranial pressure monitoring\n  3. Prior history of anaphylaxis to intravenous albumin\n  4. Contraindication or known objection to albumin\u002Fblood product transfusions\n* Already received 2 or more RRT sessions during ICU admission.\n* Limitations of medical therapy precluding RRT\u002Fmechanical ventilation\u002Fvasoactive medications or plan to transition to palliation","ALL","18 Years",{"count":272,"type":273},856,"ESTIMATED","INTERVENTIONAL",[276],"PHASE4","Study objectives:\n\nTo determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control\u002Fplacebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to:\n\n1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and\n2. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.",[279,280,281,282],"Acute Kidney Injury","Renal Replacement Therapy","Hypotension","Critical Illness",[284,15,285,286],"Albumin","Dialysis","Intensive Care Unit","2025-04-30",{"date":289,"type":290},"2025-05-01","ACTUAL",{"date":292,"type":290},"2023-11-02",{"date":294,"type":273},"2025-10-23",{"name":5,"class":6},16]