Ketamine in Acute Brain Injury Patients.
ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeert Meyfroidt, MD, PhD
About this trial
Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.
The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Traumatic brain injury patients
Age >= 18 years
Admitted to the ICU
ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugRacemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h.
Placebo
DrugPlacebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: KetamineExperimental treatment 1 intervention
Group B: PlaceboActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in therapeutic intensity of intracranial pressure (ICP) reducing measures, assessed by the TIL score (Therapy Intensity Level)
The primary efficacy endpoint will be the reduction in daily Therapy Intensity Level (TIL) score, based on the highest score in each item per day until study drug discontinuation (calculated every day on the available data at 7:00 AM). Scales for TIL score range from 0 (minimum) to 38 (maximum). Higher scores are related to worse outcome.
Time frame
From date of randomization (and start study drug) until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.Secondary outcomes
1
Intracranial pressure (ICP)
The average of hourly validated intracranial pressure (mmHg) measurements per 24 hours
Time frame
From date of randomization until study drug discontinuation or or date of death from any cause, whichever came first, assessed up to 6 months.2
Duration of sedation
Total duration of the first period of sedative treatments (propofol, midazolam and/or dexmedetomidine)
Time frame
defined as the start of the first infusion of either propofol, midazolam and/or dexmedetomidine to the cessation of the last uninterrupted infusion of either propofol, midazolam, opioids and/or dexmedetomidine, assessed up to 6 months.3
Propofol
Total dose of propofol in mg per 24 hours
Time frame
From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed at ICU discharge, assessed up to 6 months.4
Mechanical ventilation
Total duration of mechanical ventilation, defined as all types of ventilation where positive end expiratory pressure is applied, expressed in cm H2O (5 cm H2O minimum).
Time frame
From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Geert Meyfroidt, MD, PhD
Lead sponsor
KU Leuven
Sponsor institution
University of Liege
Collaborator
Centre Hospitalier Régional de la Citadelle
Collaborator
AZ Delta
Collaborator
AZ Sint-Jan AV
Collaborator
AZ Turnhout
Collaborator
Imelda Hospital, Bonheiden
Collaborator
Source ClinicalTrials.gov