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.
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Imelda Bonheiden
RECRUITING
Bonheiden
AZ Sint-Jan
RECRUITING
Bruges
Jessa Ziekenhuis
RECRUITING
Hasselt
UZLeuven
RECRUITING
Leuven
CHR de la Citadelle Liège
RECRUITING
Liège
CHU de Liège
RECRUITING
Liège
AZ Delta
RECRUITING
Roeselare
AZ Turnhout
RECRUITING
Turnhout
Contact Information
Primary
Liese Mebis, PhD
liese.mebis@uzleuven.be
003216343125
Time Frame
Start Date: 2021-09-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 100
Treatments
Experimental: 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. Study patients weighing over 120 kg will not exceed the maximum dose of 120mg/kg of ketamine.~The study medication will be started within 6 hours after randomization. The IMP, ketamine, will be provided directly to each Participating Site by the official supplier of ketamine for Belgium (Pfizer).
Active_comparator: Placebo
The 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).
Related Therapeutic Areas
Sponsors
Leads: Geert Meyfroidt, MD, PhD
Collaborators: AZ Delta, AZ Sint-Jan AV, University of Liege, Imelda Hospital, Bonheiden, AZ Turnhout, Centre Hospitalier Régional de la Citadelle