[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485045":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":92,"collaborators":7,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":7,"enrollmentInfo":104,"targetDuration":7,"studyType":107,"phases":7,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":63,"whyStopped":7,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",null,[9,12,16,19,22,25,28,31],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Preoperative data collection","Preoperatively, patients will be assessed with Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS), Clinical Frailty Scale, 3-minute Diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM, incl. severity score), modified National Institutes of Health Stroke Scale (mNIHSS), and hand grip strength measurement (using a hand dynamometer) to establish a baseline measurement of the physical, cognitive and mental status.",{"type":13,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Intraoperative NIRS","Intraoperatively, NIRS data will be collected and recorded in real-time.",{"type":13,"name":17,"description":18,"armGroupLabels":7,"otherNames":7},"Intraoperative TCD","Intraoperatively, TCD data will be collected and recorded in real-time.",{"type":13,"name":20,"description":21,"armGroupLabels":7,"otherNames":7},"Intraoperative invasive MAP","Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.",{"type":13,"name":23,"description":24,"armGroupLabels":7,"otherNames":7},"Postoperative NIRS","Postoperatively, NIRS monitoring will be continued in the ICU after the surgery until (i) endotracheal extubation, or (ii) for the first 24 hours or (iii) until emergency re-operation, whichever occurs first.",{"type":6,"name":26,"description":27,"armGroupLabels":7,"otherNames":7},"Postoperative data collection","Postoperatively patients will be evaluated for POD with 3D-CAM or CAM-ICU and for clinical stroke with mNIHSS. Postoperative neurocognitive disorders will be assessed using MoCA.",{"type":13,"name":29,"description":30,"armGroupLabels":7,"otherNames":7},"Collection of serum biomarker panel","The serum biomarker panel will consist, at least, of four markers of neurological injury glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), total tau and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1). Blood samples will be obtained preoperatively, after ICU admission, on postoperative day 1, 2, 6 (or hospital discharge, whichever occurs first) and between 6 and 12 weeks after surgery.",{"type":13,"name":32,"description":33,"armGroupLabels":7,"otherNames":7},"Collection of blood sample for genetic study","A blood sample for the genetic study will be obtained preoperatively.",[35],{"name":36,"affiliation":37,"role":38},"Nuno V. Gomes, MD","Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":7,"email":43},"CONTACT","+41 61 328 64 46","nuno.gomes@usb.ch",{"name":45,"role":41,"phone":46,"phoneExt":7,"email":47},"Luzius A. Steiner, MD, PhD","+ 41 61 328 64 74","luzius.steiner@usb.ch",[49,61,76,87],{"facility":37,"status":50,"city":51,"state":7,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":7},"COMPLETED","Basel","4031","Switzerland","CH",{"type":56,"coordinates":57},"Point",[58,59],7.57327,47.55839,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":7,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Inselspital, Bern University Hospital","RECRUITING","Bern","3010",{"type":56,"coordinates":67},[68,69],7.44744,46.94809,{"lat":69,"lon":68},[72],{"name":73,"role":41,"phone":74,"phoneExt":7,"email":75},"Dominik Günsch, MD","+41 31 632 03 77","dominik.guensch@insel.ch",{"facility":77,"status":50,"city":78,"state":7,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":7},"Cambridge University Hospitals and Brain Physics Lab","Cambridge","CB2 0QQ","United Kingdom","UK",{"type":56,"coordinates":83},[84,85],0.11667,52.2,{"lat":85,"lon":84},{"facility":88,"status":50,"city":78,"state":7,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":89,"geoPoint":91,"contacts":7},"Royal Papworth Hospital, Department of Anaesthesia and Intensive Care",{"type":56,"coordinates":90},[84,85],{"lat":85,"lon":84},{"type":93,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100485045","impact-of-personalised-cardiac-anaesthesia-and-cerebral-autoregulation-on-neurological-outcomes-in-patients-undergoing-cardiac-surgery-100485045",false,"NCT05595954","Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery","Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)","PRECISION","Inclusion Criteria:\n\n* Elective primary or reoperative coronary artery bypass graft and\u002For valvular and\u002For ascending aorta surgery requiring cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Surgery requiring moderate (28-31.9ºC) or deep (\\\u003C28ºC) hypothermic circulatory arrest;\n* Heart and\u002For lung transplantation;\n* Urgent (within 24 hours) and emergency surgery;\n* Inability to follow procedures or insufficient knowledge in English, German or French;\n* Inability to give consent.\n\nParticipants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.","ALL","65 Years",{"count":105,"type":106},500,"ESTIMATED","OBSERVATIONAL","This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.",[110,111,112],"Postoperative Delirium","Postoperative Stroke","Postoperative Cognitive Dysfunction",[114,115,116,117,118,119,120,121,122,123,124],"cerebral autoregulation","hypotension","neurological outcomes","adverse neurological events","postoperative delirium","postoperative stroke","postoperative cognitive decline","personalised cardiac anaesthesia","cardiac surgery","near-infrared spectroscopy","transcranial Doppler","2026-06-25",{"date":127,"type":128},"2026-06-30","ACTUAL",{"date":130,"type":128},"2023-01-23",{"date":132,"type":106},"2027-06",{"name":5,"class":6},4]