Actively Recruiting
Ketamine in Acute Brain Injury Patients.
Led by Geert Meyfroidt, MD, PhD · Updated on 2024-08-22
100
Participants Needed
8
Research Sites
251 weeks
Total Duration
On this page
Sponsors
G
Geert Meyfroidt, MD, PhD
Lead Sponsor
U
University of Liege
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketamine in Acute Brain Injury Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic brain injury patients
- Age 18 years or older
- Admitted to the intensive care unit (ICU)
- Within 72 hours after admission to the initial hospital:
- ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
- Requiring sedation
You will not qualify if you...
- Known pregnancy and/or lactation
- Imminent or actual brain death upon inclusion
- Allergy or intolerance to the study medication
- Pre-existing neurocognitive disorders or brain dysfunction
- Inability to obtain informed consent
- Participation in another interventional randomized controlled trial prohibiting co-inclusion
- Therapy restriction code upon inclusion
- Porphyria
- Glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Imelda Bonheiden
Bonheiden, Belgium
Actively Recruiting
2
AZ Sint-Jan
Bruges, Belgium
Actively Recruiting
3
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
4
UZLeuven
Leuven, Belgium, 3001
Actively Recruiting
5
CHR de la Citadelle Liège
Liège, Belgium
Actively Recruiting
6
CHU de Liège
Liège, Belgium
Actively Recruiting
7
AZ Delta
Roeselare, Belgium
Actively Recruiting
8
AZ Turnhout
Turnhout, Belgium
Actively Recruiting
Research Team
L
Liese Mebis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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