[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509109":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":58,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypertonic Saline Solution 3,5% (HSS)","ACTIVE_COMPARATOR",null,[13],"Drug: Sodium chloride solution 3,5%",{"label":15,"type":16,"description":11,"interventionNames":17},"Normal Saline Solution (NS)","PLACEBO_COMPARATOR",[18],"Drug: Sodium chloride solution 0,9%",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Sodium chloride solution 3,5%","Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Sodium chloride solution 0,9%","Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.",[15],[30],{"name":31,"affiliation":32,"role":33},"Fernando Bacal, PhD","University of Sao Paulo","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Ciro M Murad, MD","CONTACT","+55 31988988843","ciromurad@hotmail.com",{"name":41,"role":37,"phone":42,"phoneExt":11,"email":11},"Núcleo Transplante Heart Institute \u002F University of Sao Paulo","+55 1126615720",[44],{"facility":45,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Heart Institute, University of São Paulo.","RECRUITING","São Paulo","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-46.63611,-23.5475,{"lat":54,"lon":53},[57],{"name":36,"role":37,"phone":11,"phoneExt":11,"email":39},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Fernando Bacal","Director of Heart Transplant Unit (Heart Institute).","100509109","phase-2-hypertonic-saline-solution-to-prevent-acute-kidney-injury-after-heart-transplantation-100509109",false,"NCT05909150","Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation","Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation","HSS-HTx","Inclusion Criteria:\n\n* Hospitalized patients submitted to orthotopic heart transplantation (HT)\n\nExclusion Criteria:\n\n* Requirement of renal replacement therapy at the time of HT\n* Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT\n* Severe peri-operative mechanical complications\n* Double transplant (e.g. heart-kidney or heart-lung)\n* Hypernatremia (Na ≥ 145)\n* Severe hyponatremia (Na ≤ 120)",true,"ALL","18 Years",{"count":74,"type":75},74,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.",[81,82],"Heart Transplantation","Acute Kidney Injury","2026-04-29",{"date":85,"type":86},"2026-05-06","ACTUAL",{"date":88,"type":86},"2023-11-08",{"date":90,"type":75},"2027-03",{"name":60,"class":6},1]