RecruitingPhase 4ketamine
Ketamine in Acute Brain Injury Patients.
Sponsored by Geert Meyfroidt, MD, PhD
NCT ID
NCT05097261
Target Enrollment
100 participants
Start Date
2021-09-06
Est. Completion
2026-06-30
About This Study
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. The 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.
Conditions Studied
Interventions
- •Ketamine
- •Placebo
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Traumatic brain injury patients * Age \>= 18 years * Admitted to the ICU * Within 72 hours after admission to the initial hospital: * ICP monitoring in place (parenchymal probe, ventricular catheter, or both) * Requiring sedation Exclusion Criteria: * Known pregnancy and/or lactation * Imminent or actual brain death upon inclusion * Allergy or intolerance to the study medication * Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction. * Inability to obtain informed consent * Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited. * Therapy restriction code upon inclusion. * Porphyria * Glaucoma
Study Locations (8)
Imelda Bonheiden
Bonheiden, Belgium
AZ Sint-Jan
Bruges, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
UZLeuven
Leuven, Belgium
CHR de la Citadelle Liège
Liège, Belgium
CHU de Liège
Liège, Belgium
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium