[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522250":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":75,"collaborators":28,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":58,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Algemeen Ziekenhuis Maria Middelares","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Static group","ACTIVE_COMPARATOR","When during surgery systolic blood pressure (SBP) is below 100mmHg:\n\n* give a fluid bolus (Plasmalyte A) until 5ml\u002Fkg\u002Fh crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg\n* if the 5ml\u002Fkg\u002Fh crystalloid limit is already reached: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg\u002Fkg\u002Fmin).\n\nWhen SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.\n\nWhen SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg\u002Fkg\u002Fmin: the anaesthetist can decide to give a bolus of 6mg ephedrine intravenous (IV) (with a maximum dose of 12mg ephedrine iv per hour).",[13,14],"Drug: Plasma-lyte (static group)","Drug: Norepinephrine (static group)",{"label":16,"type":17,"description":18,"interventionNames":19},"Dynamic group","EXPERIMENTAL","After insertion of an arterial line, a pulse contour analysis system will be installed (Acumen IQ sensor, Edwards) for measuring PPV and cardiac index (CI).\n\nWhen during surgery SBP is below 100mmHg and PPV is above 12%:\n\n• give a fluid bolus (Plasmalyte A) until PPV is below or equal to 12% or SBP is above 100mmHg\n\nWhen during surgery SBP is below 100mmHg and PPV is below or equal to 12%:\n\n• start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg\u002Fkg\u002Fmin) When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.\n\nWhen SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg\u002Fkg\u002Fmin, and CI is \\\u003C 2.2 L\u002Fmin\u002Fm², a bolus of 6mg ephedrine iv will be given (with a maximum dose of 12mg ephedrine iv per hour).",[20,21],"Drug: Plasma-lyte (dynamic group)","Drug: Norepinephrine (dynamic group)",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Plasma-lyte (static group)","Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1ml\u002Fkg\u002Fh (from anaesthesia induction until ICU\u002FPACU discharge); (2) as a fluid bolus until 5ml\u002Fkg\u002Fh crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Norepinephrine (static group)","When during surgery SBP is below 100mmHg, if the 5ml\u002Fkg\u002Fh crystalloid limit is already reached, start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg\u002Fkg\u002Fmin).",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Plasma-lyte (dynamic group)","Plasmalyte will be administered intravenously:\n\n(1) as a maintenance infusion 1 ml\u002Fkg\u002Fh (from anaesthesia induction until ICU\u002FPACU discharge); (2) as a fluid bolus until PPV is below or equal to 12% or SBP is above 100mmHg.",[16],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Norepinephrine (dynamic group)","When during surgery SBP is below 100mmHg and PPV is below or equal to 12%: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg\u002Fkg\u002Fmin).\n\nWhen SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.",[16],[42],{"name":43,"affiliation":44,"role":45},"Silvie Allaert, MD","AZ Maria Middelares Gent","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+32 9 246 17 00","silvie.allaert@mijnziekenhuis.be",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},"Ella Hermie, MSc","+32 9 246 17 03","ella.hermie@mijnziekenhuis.be",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"AZ Maria Middelares","RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":65,"coordinates":66},"Point",[67,68],3.71667,51.05,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":73,"phoneExt":28,"email":74},"Steffi Ryckaert, MSc","00322461708","klinische.studies@mijnziekenhuis.be",{"type":45,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Silvie Allaert","Principal Investigator","100522250","phase-4-goal-directed-fluid-therapy-during-deep-inferior-epigastric-perforator-diep-free-flap-breast-reconstruction-100522250",false,"NCT06080178","Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction","Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial","GDFT DIEP-flap","Inclusion Criteria:\n\n* Female adult patients, between 18 and 70 years of age\n* Patients scheduled for DIEP free flap breast reconstruction\n* Signed written informed consent form (ICF)\n\nExclusion Criteria:\n\n* present atrial fibrillation (AF)\n* heart failure New York Heart Association (NYHA) classification 2 or higher\n* chronic kidney disease (CKD) stage 3B or higher\n* American Society of Anesthesiologists (ASA) classification III or higher\n* known allergy to study specific medication\n* participation in another clinical trial\n* Inability of the patient to understand Dutch sufficiently\n* Patients who are pregnant or breastfeeding","FEMALE","18 Years","70 Years",{"count":90,"type":91},82,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For this purpose, two fluid management strategies will be compared:\n\n* Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml\u002Fkg\u002Fh\n* Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.",[97],"Hypotension During Surgery",[99,100,101,102],"arterial hypotension","postoperative hypotension","Goal-directed Fluid Therapy","DIEP free flap breast reconstruction","2025-01-27",{"date":105,"type":106},"2025-01-28","ACTUAL",{"date":108,"type":106},"2023-11-23",{"date":110,"type":91},"2026-10-01",{"name":5,"class":6},1]