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
Visit trial
Status Active, not recruiting
Results Published No
Start date 30 October 2020
End date 31 December 2024
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 18- 95
Therapy No

Trial Details

Ongoing trial (n=100) sponsored by UZ Leuven in Belgium (S60859) examines Ketamine's impact on Therapy Intensity Level (TIL) and intracranial pressure in acute brain injury patients. Pfizer, EU, and UZ Leuven support the study, initiated on Oct 19, 2020, and lasting 4 years with a 6-month follow-up. Approved by the competent authority on Oct 30, 2020, and granted a favourable Ethics Committee opinion on May 3, 2021. For more information, contact UZ Leuven's Intensive Care Department.

NCT Number 2017-004698-15

Data attribution

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