[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646057":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":117,"collaborators":119,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":33,"enrollmentInfo":138,"targetDuration":33,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":56,"whyStopped":33,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Restrictive group - Low splanchnic blood volume restrictive fluid management strategy","EXPERIMENTAL","A phlebotomy (a procedure where the patient's blood is drawn, similar to a blood donation, without fluid replacement) at the start of the surgery combined with fluid restriction (use of vasopressor preferentially to treat hemodynamic instability with tolerance to relative hypovolemia defined as a Pulse Pressure Variation (PPV) or Stroke Volume (SVV) up to 18%). Fluids will be administered to compensate for blood loss and\u002For treat severe hemodynamic instability.\n\nBlood collected by phlebotomy will always be transfused back at the beginning of the reperfusion phase, during which fluid management will be based on goal-directed therapy (GDT) using either PPV or SV, as in the control group.",[13,14],"Procedure: Low splanchnic blood volume restrictive fluid management strategy","Procedure: Phlebotomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Liberal group - Optimized cardiac output liberal fluid management strategy","ACTIVE_COMPARATOR","Goal-directed therapy (GDT): Patients will receive 250 ml fluid boluses until SV stops increasing by more than 10% or until PPV is below 12%. Fluids will thus be used preferentially to treat hemodynamic instability. Fluids will also be administered to compensate for blood loss and\u002For treat severe hemodynamic instability.",[20],"Procedure: Optimized cardiac output liberal fluid management strategy",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Low splanchnic blood volume restrictive fluid management strategy","Hemodynamic goal-directed restrictive fluid management strategy",[9],[28],"Restrictive",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Phlebotomy","Blood drawn in a blood donation bag prior to dissection and transfused back after graft reperfusion",[9],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Optimized cardiac output liberal fluid management strategy","Permissive hemodynamic goal-directed fluid management strategy that optimizes cardiac output throughout surgery",[16],[39],"Liberal",[41],{"name":42,"affiliation":5,"role":43},"François Martin Carrier, MD","PRINCIPAL_INVESTIGATOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Manuela Mbacfou, MSc","CONTACT","514-890-8000","31576","manuela.mbacfou.temgoua.chum@ssss.gouv.qc.ca",{"name":42,"role":47,"phone":48,"phoneExt":33,"email":52},"francois.martin.carrier.med@ssss.gouv.qc.ca",[54,74,90,105],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Vancouver General Hospital (VGH)","RECRUITING","Vancouver","British Columbia","V5Z 1M9","Canada","CA",{"type":63,"coordinates":64},"Point",[65,66],-123.11934,49.24966,{"lat":66,"lon":65},[69,73],{"name":70,"role":47,"phone":71,"phoneExt":33,"email":72},"JeiEung Park, MD","604-875-4111","jeieung.park@vch.ca",{"name":70,"role":43,"phone":33,"phoneExt":33,"email":33},{"facility":75,"status":56,"city":76,"state":77,"zip":78,"country":60,"countryCode":61,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"London Health Sciences Centre (LHSC)","London","Ontario","N6G 2V4",{"type":63,"coordinates":80},[81,82],-81.23304,42.98339,{"lat":82,"lon":81},[85,89],{"name":86,"role":47,"phone":87,"phoneExt":33,"email":88},"Nelson Javier Gonzalez Valencia, MD","519-661-2111","nelson.gonzalezvalencia@lhsc.on.ca",{"name":86,"role":43,"phone":33,"phoneExt":33,"email":33},{"facility":5,"status":56,"city":91,"state":92,"zip":93,"country":60,"countryCode":61,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Montreal","Quebec","H2X 0C1",{"type":63,"coordinates":95},[96,97],-73.58781,45.50884,{"lat":97,"lon":96},[100,101,102],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":42,"role":43,"phone":33,"phoneExt":33,"email":33},{"name":103,"role":104,"phone":33,"phoneExt":33,"email":33},"Michaël Chassé, MD","SUB_INVESTIGATOR",{"facility":106,"status":56,"city":91,"state":92,"zip":107,"country":60,"countryCode":61,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"McGill University Health Centre (MUHC)","H4A 3J1",{"type":63,"coordinates":109},[96,97],{"lat":97,"lon":96},[112,116],{"name":113,"role":47,"phone":114,"phoneExt":33,"email":115},"Stanislas Kandelman, MD","514-934-1934","stanislas.kandelman.med@ssss.gouv.qc.ca",{"name":113,"role":43,"phone":33,"phoneExt":33,"email":33},{"type":118,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[120,123,126],{"name":121,"class":122},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":124,"class":125},"Canadian Donation and Transplantation Research Program (CDTRP)","UNKNOWN",{"name":127,"class":125},"Canadian Perioperative Anesthesia Clinical Trial (PACT) Group","100646057","restrictive-fluid-management-in-liver-transplantation-refil-100646057",false,"NCT07695363","Restrictive Fluid Management In Liver Transplantation (REFIL)","Effects of an Intraoperative Low-splanchnic Blood Volume Restrictive Fluid Management Strategy Compared to a Cardiac Output Optimized Liberal Fluid Management Strategy on Postoperative Outcomes in Liver Transplantation: A Multicenter Randomized Controlled Trial (REFIL-2)","REFIL-2","Inclusion Criteria:\n\n1. Adult ≥ 18 years old\n2. Undergoing liver transplantation (LT)\n3. End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.\n\nExclusion Criteria:\n\n1. Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD)\n2. Undergoing combined solid organ transplantations\n3. Any of the following conditions:\n\n   * severe chronic renal failure (GFR \\\u003C 15 ml\u002Fminute\u002F1.73 m2 \\[CKD-EPI equation\\] or already on renal replacement therapy (RRT))\n   * severe anemia (hemoglobin level \\\u003C 80 g\u002FL)\n   * hemodynamic instability (norepinephrine equivalent \\> 10 ug\u002Fmin)\n4. Physician refusal to enroll the patient.","ALL","18 Years",{"count":139,"type":140},866,"ESTIMATED","INTERVENTIONAL",[143],"NA","The goal of the REFIL-2 study is to evaluate the effectiveness of a low splanchnic blood volume restrictive fluid management strategy (a strategy that involves limiting fluid administration and prioritizing the use of medications that raise blood pressure during surgery, combined with phlebotomy) in improving patients' recovery after surgery. The study compares the low splanchnic blood volume restrictive fluid management strategy to an optimized cardiac-output liberal fluid management strategy (which involves administering more fluids to raise blood pressure with less reliance on medications). Outcomes important to patients will be measured.\n\nThis study (REFIL-2) had a vanguard phase (internal pilot) that included 138 patients (NCT05647733). The patients included in the vanguard pilot phase were not compared between groups but only analyzed descriptively using aggregated data. Only feasibility metrics were compared (see NCT05647733). These 138 patients were thus rolled into the REFIL-2 trial and included in the final sample size reported herein.",[146,147],"Liver Transplantation (LT)","End-stage Liver Disease (ESLD)",[149,30,150,151,152,153],"Liver Transplantation","Hemodynamic Management","Fluid Management","Transfusions","Liver Diseases","2026-07-08",{"date":156,"type":157},"2026-07-10","ACTUAL",{"date":159,"type":157},"2026-02-15",{"date":161,"type":140},"2031-11",{"name":5,"class":6},4]