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.

Phase 1

Conditions: Traumatic brain injury
MedDRA version: 26.1Level: LLTClassification code: 10060690Term: Traumatic brain injury Class: 10022117
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-505319-19-00

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Traumatic brain injury patients, Age = 18 years, Admitted to the Intensive Care Unit, Within 72 hours after admission to the initial hospital: ICP monitor in place (parenchymal probe, ventricular catheter, or both) and requiring sedation

Exclusion Criteria

Known pregnancy and/or lactation, Imminent or actual brain death upon inclusion, Allergy or intolerance to the study medication, Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction., Inability to obtain informed consent, Inclusion in an IMP-RCT of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited, Therapy restriction code upon inclusion, Porphyria, Glaucoma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that associating ketamine to the sedative regime for ICP control in TBI, results in a reduction of the therapeutic intensity of ICP reducing measures, assessed by the TIL score.;Secondary Objective: To demonstrate that ketamine does not cause an increase in ICP.;Primary end point(s): Reduction in cumulative daily TIL score., The number of high intracranial pressure episodes defined as an ICP >22 mmHg for >25 minutes

Secondary Outcome Measures