Ketamine in Acute Brain Injury Patients.

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Brain Injuries, Traumatic

In brief

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.

Key facts

Study ID

NCT05097261

Run by

Geert Meyfroidt, MD, PhD

People needed

100

Starts

2021-09-06

Expected to finish

2026-06-30

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Imelda Bonheiden — Bonheiden, Belgium (enrolling)
• AZ Sint-Jan — Bruges, Belgium (enrolling)
• Jessa Ziekenhuis — Hasselt, Belgium (enrolling)
• UZLeuven — Leuven, Belgium (enrolling)
• CHR de la Citadelle Liège — Liège, Belgium (enrolling)
• CHU de Liège — Liège, Belgium (enrolling)
• AZ Delta — Roeselare, Belgium (enrolling)
• AZ Turnhout — Turnhout, Belgium (enrolling)

Full record on ClinicalTrials.gov

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