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.
Randomised, double-blind, placebo-controlled trial (n=100) in Belgium assessing adjunctive IV ketamine (Ketalar) versus placebo to reduce Therapy Intensity Level (TIL) and monitor intracranial pressure (ICP) in acute traumatic brain injury patients.
Details
A multicentre, randomised, double-blind, placebo-controlled EEA CTA (EudraCT 2017-004698-15) evaluating whether adding intravenous ketamine to sedation regimens reduces cumulative daily Therapy Intensity Level in adults with traumatic brain injury and an ICP monitor in place.
Primary efficacy endpoint is reduction in daily TIL score; primary safety endpoint is the number of high intracranial pressure episodes (ICP >22 mmHg for >20 minutes). Secondary outcomes include mean ICP, duration of ventilation and sedation, sedative doses, ICU and hospital length of stay, delirium metrics and functional outcome (GOSE at 6 months).