[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446732":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":44,"responsibleParty":143,"collaborators":146,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":42,"enrollmentInfo":167,"targetDuration":42,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":42,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine","EXPERIMENTAL","Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg\u002Fml, undiluted. The ketamine dose is 1 mg\u002Fkg\u002Fh, to a maximum dose of 120 mg\u002Fhour, which corresponds to an infusion rate of 0.02 ml\u002Fkg\u002Fh to a maximum rate of 2.4 ml\u002Fh. Study patients weighing over 120 kg will not exceed the maximum dose of 120mg\u002Fkg of ketamine.\n\nThe study medication will be started within 6 hours after randomization. The IMP, ketamine, will be provided directly to each Participating Site by the official supplier of ketamine for Belgium (Pfizer).",[13],"Drug: Ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","ACTIVE_COMPARATOR","The placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml\u002Fkg\u002Fh to a maximum rate of 2.4 ml\u002Fh).",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg\u002Fml, undiluted. The ketamine dose is 1 mg\u002Fkg\u002Fh, to a maximum dose of 120 mg\u002Fhour, which corresponds to an infusion rate of 0.02 ml\u002Fkg\u002Fh to a maximum rate of 2.4 ml\u002Fh.",[9],[26],"Ketalar",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml\u002Fkg\u002Fh to a maximum rate of 2.4 ml\u002Fh).",[15],[31],"Saline",[33],{"name":34,"affiliation":35,"role":36},"Geert Meyfroidt, MD PhD","Associate Professor of Medicine","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Liese Mebis, PhD","CONTACT","003216343125",null,"liese.mebis@uzleuven.be",[45,60,71,84,102,113,121,132],{"facility":46,"status":47,"city":48,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Imelda Bonheiden","RECRUITING","Bonheiden","Belgium","BE",{"type":52,"coordinates":53},"Point",[54,55],4.54714,51.02261,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":42,"phoneExt":42,"email":42},"Emmanuel Van Der Hauwaert, MD",{"facility":61,"status":47,"city":62,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"AZ Sint-Jan","Bruges",{"type":52,"coordinates":64},[65,66],3.22424,51.20892,{"lat":66,"lon":65},[69],{"name":70,"role":40,"phone":42,"phoneExt":42,"email":42},"Marc Bourgeois, MD",{"facility":72,"status":47,"city":73,"state":42,"zip":74,"country":49,"countryCode":50,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Jessa Ziekenhuis","Hasselt","3500",{"type":52,"coordinates":76},[77,78],5.33781,50.93106,{"lat":78,"lon":77},[81],{"name":82,"role":40,"phone":42,"phoneExt":42,"email":83},"Jasperina Dubois, MD","jasperina.dubois@jessazh.be",{"facility":85,"status":47,"city":86,"state":42,"zip":87,"country":49,"countryCode":50,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"UZLeuven","Leuven","3001",{"type":52,"coordinates":89},[90,91],4.70093,50.87959,{"lat":91,"lon":90},[94,97,99],{"name":95,"role":40,"phone":96,"phoneExt":42,"email":43},"Liese Mebis, PhD, MSc","+3216343125",{"name":98,"role":36,"phone":42,"phoneExt":42,"email":42},"Geert JP Meyfroidt, MD, PhD",{"name":100,"role":101,"phone":42,"phoneExt":42,"email":42},"Veerle De Sloovere, MD","SUB_INVESTIGATOR",{"facility":103,"status":47,"city":104,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"CHR de la Citadelle Liège","Liège",{"type":52,"coordinates":106},[107,108],5.56749,50.63373,{"lat":108,"lon":107},[111],{"name":112,"role":40,"phone":42,"phoneExt":42,"email":42},"Hugues Maréchal, MD",{"facility":114,"status":47,"city":104,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"CHU de Liège",{"type":52,"coordinates":116},[107,108],{"lat":108,"lon":107},[119],{"name":120,"role":40,"phone":42,"phoneExt":42,"email":42},"Didier Ledoux, MD",{"facility":122,"status":47,"city":123,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"AZ Delta","Roeselare",{"type":52,"coordinates":125},[126,127],3.12269,50.94653,{"lat":127,"lon":126},[130],{"name":131,"role":40,"phone":42,"phoneExt":42,"email":42},"Peiter Lormans, MD",{"facility":133,"status":47,"city":134,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"AZ Turnhout","Turnhout",{"type":52,"coordinates":136},[137,138],4.94471,51.32254,{"lat":138,"lon":137},[141],{"name":142,"role":40,"phone":42,"phoneExt":42,"email":42},"Eva Boonen, MD, PhD",{"type":144,"investigatorFullName":145,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Geert Meyfroidt, MD, PhD",[147,149,151,152,154,155],{"name":148,"class":6},"University of Liege",{"name":150,"class":6},"Centre Hospitalier Régional de la Citadelle",{"name":122,"class":6},{"name":153,"class":6},"AZ Sint-Jan AV",{"name":133,"class":6},{"name":156,"class":6},"Imelda Hospital, Bonheiden","100446732","phase-4-ketamine-in-acute-brain-injury-patients-100446732",false,"NCT05097261","Ketamine in Acute Brain Injury Patients.","Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.","BIKe","Inclusion Criteria:\n\n* Traumatic brain injury patients\n* Age \\>= 18 years\n* Admitted to the ICU\n* Within 72 hours after admission to the initial hospital:\n\n  * ICP monitoring in place (parenchymal probe, ventricular catheter, or both)\n  * Requiring sedation\n\nExclusion Criteria:\n\n* Known pregnancy and\u002For lactation\n* Imminent or actual brain death upon inclusion\n* Allergy or intolerance to the study medication\n* Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.\n* Inability to obtain informed consent\n* Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.\n* Therapy restriction code upon inclusion.\n* Porphyria\n* Glaucoma","ALL","18 Years",{"count":168,"type":169},100,"ESTIMATED","INTERVENTIONAL",[172],"PHASE4","Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.\n\nThe BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.",[175],"Brain Injuries, Traumatic","2024-08-21",{"date":178,"type":179},"2024-08-22","ACTUAL",{"date":181,"type":179},"2021-09-06",{"date":183,"type":169},"2026-06-30",{"name":145,"class":6},8]