[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499457":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":30,"locations":39,"responsibleParty":98,"collaborators":100,"id":103,"slug":18,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":18,"enrollmentInfo":112,"targetDuration":18,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Multicomponent intervention program",[13],"Other: Multicomponent intervention program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Standard care",null,[20],{"type":6,"name":11,"description":21,"armGroupLabels":22,"otherNames":18},"Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed",[9],[24,27],{"name":25,"affiliation":5,"role":26},"Bram Tilburgs, PhD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Mark van den Boogaard, PhD","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Rens Kooken, MSc","CONTACT","+31 24 361 6735","rens.kooken@radboudumc.nl",{"name":25,"role":33,"phone":37,"phoneExt":18,"email":38},"+31 24 361 4996","bram.tilburgs@radboudumc.nl",[40,54,65,76,87],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Noordwest Ziekenhuisgroep","RECRUITING","Alkmaar","Netherlands",{"type":46,"coordinates":47},"Point",[48,49],4.74861,52.63167,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":18,"phoneExt":18,"email":18},"Wouter de Ruijter, MD, PhD",{"facility":55,"status":42,"city":56,"state":18,"zip":18,"country":44,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Bravis Ziekenhuis","Bergen op Zoom",{"type":46,"coordinates":58},[59,60],4.29167,51.495,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":18,"phoneExt":18,"email":18},"Bram Simons, MD",{"facility":66,"status":42,"city":67,"state":18,"zip":18,"country":44,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Amphia Ziekenhuis","Breda",{"type":46,"coordinates":69},[70,71],4.77596,51.58656,{"lat":71,"lon":70},[74],{"name":75,"role":33,"phone":18,"phoneExt":18,"email":18},"Thijs Rettig, MD, PhD",{"facility":77,"status":42,"city":78,"state":18,"zip":18,"country":44,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Elkerliek Ziekenhuis","Helmond",{"type":46,"coordinates":80},[81,82],5.66111,51.48167,{"lat":82,"lon":81},[85],{"name":86,"role":33,"phone":18,"phoneExt":18,"email":18},"Rens van de Weyer, MD",{"facility":88,"status":42,"city":89,"state":18,"zip":18,"country":44,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"VieCuri Medisch Centrum","Venlo",{"type":46,"coordinates":91},[92,93],6.16806,51.37,{"lat":93,"lon":92},[96],{"name":97,"role":33,"phone":18,"phoneExt":18,"email":18},"Quirine Habes, MD, PhD",{"type":99,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[101],{"name":102,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100499457",false,"NCT05783505","A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use","PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention","PRAISE","Inclusion criteria:\n\n* Adult ICU patients (aged ≥18) with an expected ICU stay of \\>24 hours\n* Patients who are (expected to become) agitated within the first 14 days of their ICU admission\n\nExclusion criteria:\n\n* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known\u002Fsuspected hypersensitivity);\n* Neurological patients with an (expected risk of) increased intracranial pressure;\n* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);\n* Support with Extracorporeal Membrane Oxygenation (ECMO);\n* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);\n* A high risk of physical aggression towards healthcare professionals;\n* No consent for long term follow up in the MONITOR-IC study;\n* Not able to read or understand the Dutch language and no relatives able to assist;\n* Enrolment in other sedation studies.","ALL","18 Years",{"count":113,"type":114},480,"ESTIMATED","INTERVENTIONAL",[117],"NA","Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.",[120],"Agitation,Psychomotor",[122,123,124,125,126],"ICU","Agitation","Physical Restraints","Non-pharmacologic interventions","Dexmedetomidine","2025-06-12",{"date":129,"type":130},"2025-06-17","ACTUAL",{"date":132,"type":130},"2023-06-01",{"date":134,"type":114},"2026-10-01",{"name":5,"class":6},5]