[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565617":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":86,"collaborators":12,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":12,"maxAge":96,"enrollmentInfo":97,"targetDuration":12,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":116,"whyStopped":12,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Observation of current local practices","NO_INTERVENTION","Current local practices regarding fluid management will be observed. Population: Critically ill children receiving mechanical ventilation due to respiratory insufficiency. Patients will be treated according to local protocols at the discretion of the attending physicians.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Strict adherence to european guidelines","ACTIVE_COMPARATOR","In this intervention attending physicians will be encouraged to strictly adhere the European (ESPNIC) guidelines regarding fluid management.",[18],"Other: Strict adherence to European guidelines",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Strict adherence to European guidelines","The goal is to maintain a neutral fluid balance throughout the course of intubation if clinical practice allows. Therefore:\n\n* From the start of mechanical ventilation, the maximum maintenance fluids is 65% of the maintenance fluids proposed by the Holliday \\& Segar formula. Fluid resuscitation in the first hours after intubation is at the discretion of the attending physician.\n* Any other interventions to maintain a neutral fluid balance (e.g., starting diuretics, reducing fluid boluses, decreasing creep fluids, or using more concentrated enteral feeding) are at the discretion of the attending physician.\n* Throughout the intervention, the attending physician decides if clinical practice allows for a decrease in fluid balance, and international feeding goals must always be met.",[14],[25],{"name":26,"affiliation":5,"role":27},"Joris Lemson, MD PhD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","0031243617273","joris.lemson@radboudumc.nl",{"name":34,"role":30,"phone":31,"phoneExt":12,"email":35},"Michiel Schwerzel, MSc","michiel.schwerzel@radboudumc.nl",[37,54,70],{"facility":38,"status":12,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Radboudumc","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],5.85278,51.8425,{"lat":48,"lon":47},[51,53],{"name":34,"role":30,"phone":52,"phoneExt":12,"email":35},"+31 243617273",{"name":26,"role":30,"phone":12,"phoneExt":12,"email":12},{"facility":55,"status":12,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Amsterdam MC","Amsterdam","North Holland","1100 DD",{"type":45,"coordinates":60},[61,62],4.88969,52.37403,{"lat":62,"lon":61},[65,69],{"name":66,"role":30,"phone":67,"phoneExt":12,"email":68},"Reinout Bem, MD PhD","+31 566 8000","r.a.bem@amsterdamumc.nl",{"name":66,"role":30,"phone":12,"phoneExt":12,"email":12},{"facility":71,"status":12,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"ErasmusMC","Rotterdam","South Holland","3015 CN",{"type":45,"coordinates":76},[77,78],4.47917,51.9225,{"lat":78,"lon":77},[81,85],{"name":82,"role":30,"phone":83,"phoneExt":12,"email":84},"Hanneke Bakker, MD PhD","+31 10703 62 55","johanna.bakker@erasmusmc.nl",{"name":82,"role":30,"phone":12,"phoneExt":12,"email":12},{"type":87,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100565617","the-efficient-picu-fluid-care-evaluation-100565617",false,"NCT06644508","The Efficient PICU Fluid Care Evaluation","LESSER-2","Inclusion Criteria:\n\n* Age \\\u003C 10 years and weight \\\u003C 35 kg\n* Receiving invasive mechanical ventilation (IMV) due to respiratory failure\n* Inclusion possible within 24 hours of start of IMV\n* Expected duration of IMV \\> 48 hours\n\nExclusion Criteria:\n\n* Preterm (\\\u003C37weeks gestational age)\n* Preexistent (clinical) diagnosis of kidney disease\n* Congenital cardiac defect with hemodynamic consequences or reduced cardiac function\n* (Ongoing) shock with need for fluid resuscitation and\u002For vasoactive drugs\n* Cardiovascular (including diuretics) drug use on admission (home medication)\n* Pre-existent (clinical) diagnosis of liver failure\n* Right of left heart failure\n* Pulmonary hypertension\n* ECMO treatment\n* Receiving total parenteral nutrition on admission which won't be stopped\n* Failure to include within 12 hours after start of IMV\n* Expected duration of IMV \\\u003C 48 hours\n* Parents or caretakers unable to understand\u002Fspeak Dutch language\n* Surgery \\\u003C 48 hours","ALL","10 Years",{"count":98,"type":99},90,"ESTIMATED","INTERVENTIONAL",[102],"NA","The goal of this clinical trial is to evaluate and prevent fluid overload in critically ill, mechanically ventilated children. The main questions it aims to answer are:\n\n1. What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?\n2. What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?\n\nResearchers will compare the effects of strict adherence to the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) guidelines regarding fluid balance (i.e. restricting fluid intake and preventing a positive fluid balance) to current local practice.\n\nFrom the start to the end of invasive mechanical ventilation participants will be treated according to local practice or with the strict aim to prevent a positive fluid balance. Aiming to prevent a positive fluid balance, if this is possible given the clinical context, is at descretion of the attending physician. Minimal caloric intake requirements must be met.\n\nParticipants are studied for ten days during invasive mechanical ventilation or until discharge from the intensive care",[105,106,107],"Respiratory Insufficiency Requiring Mechanical Ventilation","Fluid Overload","Fluid Balance",[109,110,111,107,112,106,113,114,115],"Respiratory Insufficiency","Mechanical ventilation","Fluids","Edema","Lenght of mechanical ventilation","Childeren","Maintenance fluids","NOT_YET_RECRUITING","2024-10-14",{"date":119,"type":120},"2024-10-16","ACTUAL",{"date":122,"type":99},"2024-10",{"date":124,"type":99},"2025-05",{"name":5,"class":6},3]