Ketamine in Acute Brain Injury Patients.

Phase 4

Recruiting

• Conditions: Brain Injuries, Traumatic

• Registration Number: NCT05097261
• Lead Sponsor: Geert Meyfroidt, MD, PhD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-9-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> - Traumatic brain injury patients<br><br> - Age >= 18 years<br><br> - Admitted to the ICU<br><br> - Within 72 hours after admission to the initial hospital:<br><br> - ICP monitoring in place (parenchymal probe, ventricular catheter, or both)<br><br> - Requiring sedation<br><br>Exclusion Criteria:<br><br> - Known pregnancy and/or lactation<br><br> - Imminent or actual brain death upon inclusion<br><br> - Allergy or intolerance to the study medication<br><br> - Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital<br> brain dysfunction.<br><br> - Inability to obtain informed consent<br><br> - Inclusion in an interventional randomised controlled trial of which the PI indicates<br> that co-inclusion specifically in the BIKe study is prohibited.<br><br> - Therapy restriction code upon inclusion.<br><br> - Porphyria<br><br> - Glaucoma

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in therapeutic intensity of intracranial pressure (ICP) reducing measures, assessed by the TIL score (Therapy Intensity Level)

Secondary Outcome Measures

Name	Time	Method
Intracranial pressure (ICP);Duration of sedation;Propofol;Mechanical ventilation;Midazolam;ICU length of stay;Hospital length of stay;Richmond Agitation-Sedation scale (RASS);Delirium;eGOS;ICU mortality;In-hospital mortality;Barbiturate coma incidence;Barbiturate coma duration;Decompressive craniectomy;Propofol Infusion Syndrome (PRIS)