[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371317":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital Hradec Kralove","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A invasive haemodynamical measurement","ACTIVE_COMPARATOR","No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml\u002Fkg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml\u002Fkg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.",[13],"Procedure: Hemodynamic management based on invasive fluid responsiveness parameters",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B non-invasive haemodynamical measurement","EXPERIMENTAL","No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).",[19],"Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Hemodynamic management based on invasive fluid responsiveness parameters","In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml\u002Fkg of Plasmalyte (Baxter)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Hemodynamic management based on noninvasive cardiac output and SVV measurement","In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.",[15],[32],{"name":33,"affiliation":5,"role":34},"Pavel Dostal, MD, Ph.D.","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Vlasta Dostálová, MD, Ph.D.","CONTACT","777883571","dostavla@seznam.cz",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":43},"+420495833218","pavel.dostal@fnhk.cz",[45],{"facility":5,"status":46,"city":47,"state":26,"zip":48,"country":49,"countryCode":26,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Hradec Králové","50005","Czechia",{"type":51,"coordinates":52},"Point",[53,54],15.83277,50.20923,{"lat":54,"lon":53},[57,60],{"name":58,"role":38,"phone":59,"phoneExt":26,"email":43},"Pavel Dostal, MD, PhD","00420495833218",{"name":58,"role":38,"phone":61,"phoneExt":26,"email":43},"00420495832266",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dostalova Vlasta, MD, PhD","principal investigator","100371317","haemodynamical-optimization-during-brain-surgery-100371317",false,"NCT04114799","Haemodynamical Optimization During Brain Surgery","A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery","Inclusion Criteria:\n\n* Glasgow Coma scale 15\n* ASA Physical Status Classification System I-III\n* planed surgery for brain tumor to 5 hours\n* postoperative awakening\n* sinus rhythm\n\nExclusion Criteria:\n\n* NYHA III, IV\n* BMI over 40 in females and over 35 in men\n* awake operation\n* postoperative artificial ventilation","ALL","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV\u002FPPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).",[83],"Brain Edema",[85,86,87],"fluid responsiveness","haemodynamical monitoring","ClearSight","2024-05-09",{"date":90,"type":91},"2024-05-10","ACTUAL",{"date":93,"type":91},"2019-04-01",{"date":95,"type":77},"2026-11-30",{"name":5,"class":6},1]