Using ketamine for sedation in patients with traumatic brain injuries
Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.
This study is testing if adding ketamine to regular sedation methods can help adults with traumatic brain injuries feel more comfortable and manage their symptoms better in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 8 sites (Bonheiden and 7 other locations) |
| Trial ID | NCT05097261 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and feasibility of ketamine as an adjunct to standard sedation strategies in adult patients with traumatic brain injuries (TBI). It is a double-blind, placebo-controlled, randomized multicenter trial where participants will receive either ketamine or a placebo alongside standard sedatives like propofol and midazolam. The study aims to assess the effects of ketamine on therapy intensity levels and intracranial pressure (ICP) in TBI patients admitted to the ICU within 72 hours of injury. The trial will also monitor the decision-making process regarding sedation management and potential surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with traumatic brain injuries who require sedation and have ICP monitoring in place.
Not a fit: Patients who are pregnant, have imminent brain death, or have pre-existing neurocognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sedation management and outcomes for patients with traumatic brain injuries.
How similar studies have performed: While the use of ketamine in TBI patients has been reported, this study is among the first to rigorously evaluate its efficacy through a randomized controlled trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bonheiden and 7 other locations
- Imelda Bonheiden — Bonheiden, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- UZLeuven — Leuven, Belgium (Recruiting)
- CHR de la Citadelle Liège — Liège, Belgium (Recruiting)
- CHU de Liège — Liège, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
Study contacts
- Principal investigator: Geert Meyfroidt, MD PhD — Associate Professor of Medicine
- Study coordinator: Liese Mebis, PhD
- Email: liese.mebis@uzleuven.be
- Phone: 003216343125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.