CTIS2023-505319-19-00Active, not recruitingPhase 1
Brain Injury and Ketamine: a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in acute brain injury patients. - S60859
Z Leuven0 sites100 target enrollmentStarted: January 29, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Traumatic brain injury patients, Age = 18 years, Admitted to the Intensive Care Unit, Within 72 hours after admission to the initial hospital: ICP monitor in place (parenchymal probe, ventricular catheter, or both) and 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 IMP-RCT of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited, Therapy restriction code upon inclusion, Porphyria, Glaucoma
Investigators
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