Ketamine in Acute Brain Injury Patients.

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geert Meyfroidt, MD, PhD
• Collaborators: AZ Delta; AZ Sint-Jan AV; AZ Turnhout; Centre Hospitalier Régional de la Citadelle; University of Liege
• Treatments: Ketamine

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