The use of ketamine in acute brain injury patients.
- Conditions
- Traumatic Brain Injury patients requiring sedation to control the intracranial pressure (ICP).Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2017-004698-15-BE
- Lead Sponsor
- Z Leuven / KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
* Traumatic brain injury patients
* Age = 18 years
* Admitted to the ICU
* Within 72 hours after admission to the initial hospital:
1)ICP monitor in place (parenchymal probe, ventricular catheter, or both)
2)Requiring sedation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
* 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): Primary efficacy endpoint: Reduction in cumulative daily TIL score. Primary safety endpoint: The number of high intracranial pressure episodes defined as an ICP >22 mmHg for >20 minutes [1,2].<br>;Timepoint(s) of evaluation of this end point: Daily
- Secondary Outcome Measures
Name Time Method Secondary end point(s): * The average intracranial pressure (mmHg) per 24h <br>* Total duration of the first episode of sedative treatment (hours) <br>* Total duration of the first episode of mechanical ventilation <br>* Total dose of propofol in mg per 24 hours <br>* Total dose of midazolam in mg per 24 hours <br>* Length of stay in the Intensive Care Unit (ICU) <br>* Length of stay in the hospital (days) <br>* Average daily Richmond agitation and sedation score (RASS) (addendum 2) per hour <br>* Delirium-free days, defined with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method-ICU (CAM-ICU) every 8 hours (ICDSC) <br>* Extended Glasgow Outcome Score (GOSE) at 6 months after the onset of brain injury <br>* The incidence of barbiturate coma <br>* Incidence of decompressive craniectomy <br>* Incidence of Propofol-Related Infusion Syndrome (PRIS)<br>;Timepoint(s) of evaluation of this end point: As described in E.5.2