[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Geert Meyfroidt, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Brain Injuries, Traumatic","RECRUITING","2024-08-21",{"date":31,"type":32},"2024-08-22","ACTUAL",{"date":34,"type":32},"2021-09-06",{"date":36,"type":21},"2026-06-30",{"name":38,"class":39},"Geert Meyfroidt, MD, PhD","OTHER",8,""]