Ketamine in Acute Brain Injury Patients

This double-blind, placebo-controlled randomized multicenter clinical trial (n=100) aims to investigate the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in Traumatic Brain Injury (TBI) patients.

The Brain Injury and Ketamine (BIKe) study will assess the effects of ketamine as an adjunct to standard sedation regimes in adult TBI patients. All patients will initially receive propofol for sedation to control intracranial pressure (ICP), with midazolam added if necessary. The study medication (ketamine or placebo) will then be administered after randomization. Decisions regarding decompressive craniectomy and/or barbiturate coma will be made based on multidisciplinary consultation.

The primary outcome measure will be the reduction in daily Therapy Intensity Level (TIL) score, reflecting the therapeutic intensity of ICP-reducing measures. Secondary outcome measures include intracranial pressure, duration of sedation, mechanical ventilation, ICU and hospital length of stay, among others.

The study is conducted at multiple sites in Belgium and is estimated to be completed by December 2024.

Topic Traumatic Brain Injury
Compound Ketamine Placebo
Country Belgium
Visit trial
Status Recruiting
Results Published No
Start date 06 September 2021
End date 31 December 2024
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 18- 99
Therapy No

Trial Details

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.

NCT Number NCT05097261

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.