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.

This randomised, double-blind, placebo-controlled trial (n=100) sponsored by UZ Leuven / KU Leuven in Belgium (S60859) explores the use of ketamine in acute brain injury (TBI) patients to study its effects on Therapy Intensity Level (TIL) and intracranial pressure (ICP).

The trial involves trauma patients aged 18 and above, admitted to the ICU within 72 hours of hospitalization, with ICP monitoring in place and requiring sedation. The primary objective is to demonstrate that ketamine reduces the therapeutic intensity of ICP control, assessed by the TIL score, without increasing ICP.

The trial’s end date is anticipated to be 4 years from the start date, with a follow-up lasting 6 months after the onset of traumatic brain injury (TBI). The study has received support from Pfizer, the European Union, and UZ Leuven. The trial is ongoing and received approval from the Competent Authority on October 30, 2020, and a favourable opinion from the Ethics Committee on May 3, 2021.

Topic Traumatic Brain Injury
Compound Ketamine
Country Belgium
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