[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598398":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Proactive monitoring","EXPERIMENTAL","The patients will be managed following an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as \"medium\" during cytoreductive phase and \"restrictive\" during HIPEC.",[13],"Device: Assisted Fluid Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Goal Directed Fluid Therapy (GDT)","ACTIVE_COMPARATOR","The patients have been managed following institutional algorithm aimed to optimize stroke volume index and reduce intraoperative hypotension",[19],"Other: Goal Directed Fluid Therapy (GDT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Assisted Fluid Management","Intraoperative fluid infusion will be regulated according to the Assisted Fluid Management (AFM) software and on Hypotension Prediction Index (HPI) will be used to titrate vasopressors and inotropes.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension",[15],[31],{"name":32,"affiliation":5,"role":33},"Luciano Frassanito","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Luciano Frassanito, MD","CONTACT","+393475256158","luciano.frassanito@policlinicogemelli.it",[41],{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"IRCCS Fondazione Policlinico A. Gemelli","RECRUITING","Rome","00167","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],12.51133,41.89193,{"lat":52,"lon":51},[55,57],{"name":56,"role":37,"phone":38,"phoneExt":26,"email":39},"Frassanito Luciano",{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Frassanito Luciano, MD","SUB_INVESTIGATOR",{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"FRASSANITO LUCIANO","Dr Luciano Frassanito","100598398","proactive-hemodynamic-management-during-cytoreductive-surgery-and-hipec-100598398",false,"NCT07070973","Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC","HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer","HEMOPEC","Inclusion Criteria:\n\n* age \\> 18 years\n* patient scheduled for CRS for ovarian cancer\n\nExclusion Criteria:\n\n* patients' refusal\n* cardiac arrythmia\n* pregnancy.","FEMALE","18 Years",{"count":74,"type":75},52,"ESTIMATED","INTERVENTIONAL",[78],"NA","Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion\u002Foedema are the most frequent postoperative complications.\n\nIntraoperative hypotension and risk of fluid overload are common. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC.\n\nThe aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization.\n\nSpecifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time \"in-target\" range of SV index.\n\nThe study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.",[81,82,83],"Ovarian Cancer","Hemodynamic Instability","Fluid Overload","2026-05-06",{"date":86,"type":87},"2026-05-11","ACTUAL",{"date":89,"type":87},"2025-09-01",{"date":91,"type":75},"2027-02-01",{"name":5,"class":6},1]