Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ketamine in Acute Brain Injury Patients.
Sponsor: Geert Meyfroidt, MD, PhD
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-09-06
Completion Date
2026-06-30
Last Updated
2024-08-22
Healthy Volunteers
No
Conditions
Interventions
Ketamine
Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h.
Placebo
Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).
Locations (8)
Imelda Bonheiden
Bonheiden, Belgium
AZ Sint-Jan
Bruges, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
UZLeuven
Leuven, Belgium
CHR de la Citadelle Liège
Liège, Belgium
CHU de Liège
Liège, Belgium
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium