Ketamine in Acute Brain Injury Patients.

Launched by GEERT MEYFROIDT, MD, PHD · Oct 15, 2021

Keywords

ClinConnect Summary

The BIKe study is a clinical trial that is looking at the use of ketamine, a medication often used for sedation, in patients with traumatic brain injuries (TBI). The goal of the study is to see if adding ketamine to standard sedation methods is safe and effective for these patients. This research is important because, although ketamine has been used more frequently in recent years for patients with brain injuries, there hasn't been enough evidence from clinical trials to support its use.

To be eligible for this trial, participants must be at least 18 years old, have a traumatic brain injury, and be admitted to the intensive care unit (ICU) within 72 hours of their injury. They should also have a monitoring device in place to track pressure inside the brain and require sedation. However, some patients cannot participate, such as those who are pregnant, have certain pre-existing medical conditions, or are unable to give consent. Those who join the study will receive either ketamine or a placebo (a sugar pill with no active medication) without knowing which one they are getting. This helps researchers understand how effective ketamine is compared to standard treatment.

Gender

ALL

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