[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382972":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":40,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Istituto Clinico Humanitas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Near Infrared Spectroscopy (NIRS)","EXPERIMENTAL",null,[13],"Device: Near Infrared Spectroscopy (NIRS)",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard Care","ACTIVE_COMPARATOR",[18],"Device: Standard Care",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","The anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission.\n\nWhen a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Controls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS.",[15],[28],{"name":29,"affiliation":30,"role":31},"Maurizio Cecconi, Prof, MD","Humanitas Research Hospital IRCCS, Rozzano-Milan","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","0282244115","maurizio.cecconi@hunimed.eu",{"name":38,"role":34,"phone":11,"phoneExt":11,"email":39},"Massimiliano Greco, MD","massimiliano.greco@hunimed.eu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Humanitas Research Hospital","RECRUITING","Rozzano","Milan","20089","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],9.1559,45.38193,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":11,"phoneExt":11,"email":11},"Maurizio Cecconi, MD",{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100382972","brain-targeted-goal-directed-therapy-in-high-risk-patients-undergoing-major-elective-surgery-the-brain-promise-study-100382972",false,"NCT04266574","BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study","BRAINPROMISE","Inclusion Criteria:\n\n* hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5\n* presence of an arterial catheter during anesthesia\n* planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia\n* ability to give informed consent according to International Conference on Harmonization ICH\u002F Good Clinical Practice (GCP), and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Unable to consent to study inclusion\n* Language barrier\n* Severe neurological or psychiatric disease\n* End-stage dementia\n* Total Intravenous anesthesia\n* No use of hypertensive medication at home.","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"NA","The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.",[77,78],"Surgery","Perioperative Complication","2024-10-21",{"date":81,"type":82},"2024-10-23","ACTUAL",{"date":84,"type":82},"2020-11-17",{"date":86,"type":71},"2024-12",{"name":5,"class":6},1]