Ketamine in Acute Brain Injury Patients.
ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeert Meyfroidt, MD, PhD
About this trial
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.
Eligibility criteria
Qualifiers
Traumatic brain injury patients
Age >= 18 years
Admitted to the ICU
ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketamine
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Geert Meyfroidt, MD, PhD
Lead sponsor
KU Leuven
Sponsor institution
University of Liege
Collaborator
Centre Hospitalier Régional de la Citadelle
Collaborator
AZ Delta
Collaborator
AZ Sint-Jan AV
Collaborator
AZ Turnhout
Collaborator
Imelda Hospital, Bonheiden
Collaborator
Source ClinicalTrials.gov