[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100321789":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":25,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Instituto do Coracao","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Goal-directed therapy","ACTIVE_COMPARATOR","Patients randomized to this group will be monitoring by continuous central venous oxygen saturation. Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic.",[13],"Other: Continuous central venous oxygenation monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard protocol","OTHER","The control group will keep the standard therapy.",[19],"Other: Standard protocol",[21,26],{"type":16,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Continuous central venous oxygenation monitoring","Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic.\n\n* First, isotonic crystalloid, 10 up to 20 mL\u002Fkg, will be administered in boluses to achieve continuous central venous oxygen saturation higher than 65% in non-cyanogenic and 55% in cyanogenic.\n* Second, if not achieved with fluid administration, will be targeted by initiating and titrating inotropics (dobutamine or milrinone). If the mean arterial pressure is lower than 50 mm Hg will be associated epinephrine.\n* If the ScvO2 is lower than 65% in non-cyanogenic and 55% in cyanogenic and the hemoglobin was lower than 8g\u002Fdl, red blood cells (20mL\u002FKg) will be transfused to achieve a hemoglobin level of at least 8g\u002FdL.",[9],null,{"type":16,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The control group will keep the standard therapy to achieve mean arterial pressure higher than 50mmHg, central venous pressure 8 to 12 mmHg, urinay debit higher than 0,5ml\u002Fkg\u002Fh, hemoglobin higher or equal than 8g\u002FdL, arterial oxygen saturation higher or equal than 92% in non-cyanogenic and 80% cyanogenic, central venous oxygen saturation higher or equal than 65% in non-cyanogenic and 55% in cyanogenic.",[15],[30],{"name":31,"affiliation":32,"role":33},"Flavio M Ferreira, Phd","HCFUSP","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Filomena G Galas, Phd","CONTACT","+55 11 99319-0441","filomenagalas@hotmail.com",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Incor - Heart Institute - University of Sao Paulo","RECRUITING","São Paulo","05403000","Brazil","BR",{"type":49,"coordinates":50},"Point",[51,52],-46.63611,-23.5475,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":39},"Filomena RG Galas","+551126615232",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Filomena R B G Galas","Associate Professor of Anesthesiology Departament","100321789","goal-directed-therapy-aiming-to-optimise-oxygen-central-venous-saturation-in-children-undergoing-cardiac-surgery-100321789",false,"NCT03469440","Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery","Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial","Inclusion Criteria:\n\n* Elective cardiac surgery with cardiopulmonary bypass\n* Written informed consent\n\nExclusion Criteria:\n\n* Cardiac arrhythmia\n* Emergency operation\n* Hemodynamic instabillty (norepinephrine higher than 1 mcg\u002Fkg\u002Fmin)\n* Neoplasia\n* Heart transplant\n* Participation in another study","ALL","14 Years",{"count":71,"type":72},65,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.",[78,79],"Heart; Dysfunction Postoperative, Cardiac Surgery","C.Surgical Procedure; Cardiac",[81,82,83],"lactate","central venous saturation","Pediatric Cardiac Surgery","2024-08-21",{"date":86,"type":87},"2024-08-23","ACTUAL",{"date":89,"type":87},"2018-02-01",{"date":91,"type":72},"2024-12",{"name":5,"class":6},1]