[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":70,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":26,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydroxyethyl starch","EXPERIMENTAL","Hydroxyethyl starch is used (up to 20 mL\u002Fkg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery",[13],"Drug: Volulyte® (6% HES 130\u002F0.4 in balanced solution)",{"label":15,"type":16,"description":17,"interventionNames":18},"Ballanced crystalloid","ACTIVE_COMPARATOR","Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required \\[e.g., preload augmentation, intravascular volume replacement\\] during cardiac surgery).",[19],"Drug: Crystalloid solutions",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Volulyte® (6% HES 130\u002F0.4 in balanced solution)","Hydroxyethyl starch is used (up to 20 mL\u002Fkg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Crystalloid solutions",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Karam Nam, M.D., Ph.D.","CONTACT","+82 2 2072 0643","karamnam@gmail.com",[37,49,58,65],{"facility":38,"status":39,"city":40,"state":26,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Chungnam National University Hospital","RECRUITING","Daejeon","35015","South Korea",{"type":44,"coordinates":45},"Point",[46,47],127.38493,36.34913,{"lat":47,"lon":46},{"facility":50,"status":39,"city":51,"state":26,"zip":52,"country":42,"countryCode":26,"cosmosGeoPoint":53,"geoPoint":57,"contacts":26},"Korea University Guro Hospital","Seoul","03080",{"type":44,"coordinates":54},[55,56],126.9784,37.566,{"lat":56,"lon":55},{"facility":5,"status":39,"city":51,"state":26,"zip":52,"country":42,"countryCode":26,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},{"type":44,"coordinates":60},[55,56],{"lat":56,"lon":55},[63],{"name":64,"role":33,"phone":34,"phoneExt":26,"email":35},"Karam Nam",{"facility":66,"status":39,"city":51,"state":26,"zip":52,"country":42,"countryCode":26,"cosmosGeoPoint":67,"geoPoint":69,"contacts":26},"Severance Hospital",{"type":44,"coordinates":68},[55,56],{"lat":56,"lon":55},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Karam Nam, MD","Clinical Associate Professor","100624542","phase-4-hydroxyethyl-starch-versus-crystalloid-and-postoperative-major-adverse-kidney-complications-100624542",false,"NCT07410988","Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications","Effect of 130\u002F0.4 Hydroxyethyl Starch vs. Balanced Crystalloid for Intraoperative Fluid Therapy on Major Composite Renal Outcomes After Cardiac Surgery: a Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and\u002For thoracic aortic surgery\n\nExclusion Criteria:\n\n1. Emergency surgery;\n2. Planned implantation of a durable left ventricular assist device;\n3. History of starch allergy or hypersensitivity;\n4. History of kidney transplantation;\n5. Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT);\n6. Preoperative glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n7. Planned intraoperative and postoperative RRT;\n8. Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.);\n9. Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count \\\u003C100,000\u002FµL);\n10. Active infective endocarditis.","ALL","19 Years",{"count":84,"type":85},1292,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.",[91],"Cardiac Surgery",[93],"hydroxyethyl starch","2026-06-21",{"date":96,"type":97},"2026-06-24","ACTUAL",{"date":99,"type":97},"2026-06-22",{"date":101,"type":85},"2029-07-31",{"name":5,"class":6},4]