[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600784":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":24,"responsibleParty":42,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":24,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":24},{"fullName":5,"class":6},"Brno University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard monitoring","ACTIVE_COMPARATOR","In this arm standard monitoring of vital signs will be used during operation.",[13],"Other: Standard monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Goal-Directed Therapy","EXPERIMENTAL","A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring.",[19],"Other: Goal-Directed Therapy",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Administration of fluids and vasoactive drugs guided by standard vital signs monitoring",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring",[15],[29],{"name":30,"affiliation":5,"role":31},"Veronika Kočí, M.D.","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Roman Gál, prof.","CONTACT","+420 532 233 850","gal.roman@fnbrno.cz",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Ondřej Hrdý, M.D.","+420 532 232 009","hrdy.ondrej@fnbrno.cz",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Roman Gal","Head of the department",[47,49],{"name":48,"class":6},"Military University Hospital, Prague",{"name":50,"class":51},"Zlin Regional Hospital","UNKNOWN","100600784","effects-of-gdht-goal-directed-hemodynamic-therapy-using-a-non-invasive-hemodynamic-monitoring-in-elective-neurosurgery-100600784",false,"NCT07101991","Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery","Effects of Goal-directed Fluid Management Guided by a Non-invasive Device on the Incidence of Postoperative Complications in Neurosurgery: a Multicenter, Prospective, Randomized, Controlled Study","NCHGDT","Inclusion Criteria:\n\nSubjects will be eligible for the trial if they meet all of the following criteria:\n\n* Age ≥ 18 years\n* Elective brain surgery with an expected duration ≥ 2 h\n* Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification\n* Lateral or supine operative position\n* Signed the relevant informed consent form\n\nExclusion Criteria:\n\nSubjects will not be eligible for the trial if they meet any of the following criteria:\n\n* Category 4 according to the ASA Physical Status Classification\n* Surgery for traumatic brain injury or acute hemorrhagic stroke\n* Awake brain surgery\n* Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)\n* Unavailability of hemodynamic monitoring data\n* Cardiac arrhythmia with irregular cardiac rhythm\n* Known hypersensitivity to the active substance or to any of the excipients of IMP (Investigational Medicinal Product)\n* Pregnancy and lactation","ALL","18 Years",{"count":63,"type":64},140,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.",[70],"Surgery Complications",[72,73,74],"neurosurgery","goal-directed therapy","adverse events","NOT_YET_RECRUITING","2025-07-28",{"date":78,"type":79},"2025-08-03","ACTUAL",{"date":81,"type":64},"2025-09",{"date":83,"type":64},"2028-11",{"name":5,"class":6}]