Ketamine in Acute Brain Injury Patients.

Phase 4 Recruiting 100 enrolled Geert Meyfroidt, MD, PhD AZ Delta · collab AZ Sint-Jan AV · collab AZ Turnhout · collab Centre Hospitalier Régional de la Citadelle · collab Imelda Hospital, Bonheiden · collab University of Liege · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

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.

Timeline

Start: 2021-09-06
Primary completion: 2025-12-31
Completion: 2026-06-30

Publications

De Sloovere V, Mebis L, Wouters P, Guiza F, Boonen E, Bourgeois M, Dubois J, Ledoux D, Lormans P, Marechal H, Van der Hauwaert E, Depreitere B, Meyfroidt G. Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients. Trials. 2025 May 28;26(1):177. doi: 10.1186/s13063-025-08835-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	1 mg/kg	Other

Ketamine in Acute Brain Injury Patients.

Summary

Timeline

Publications

Drugs

Indications