Clinical TrialTraumatic Brain Injury (TBI)KetaminePlaceboRecruiting

Ketamine in Acute Brain Injury Patients

This double-blind, placebo-controlled randomized multicentre clinical trial (n=100) aims to investigate the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in Traumatic Brain Injury (TBI) patients.

Target Enrollment
100 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

The BIKe study is a double-blind, placebo-controlled randomised multicentre trial evaluating racemic ketamine as an adjunct to standard sedation in adult TBI patients, with primary outcomes including intracranial pressure control and therapy intensity level.

Racemic ketamine is administered as a continuous infusion (1 mg/kg/h, max 120 mg/h; infusion rate 0.02 ml/kg/h, max 2.4 ml/h; concentration 50 mg/ml) started after randomisation; background sedation uses propofol (up to 4 mg/kg/h) with addition of midazolam if required, and opioids for analgesia, per site standard care.

Study Arms & Interventions

Ketamine infusion

experimental

Continuous racemic ketamine infusion as adjunct to standard sedation for TBI patients.

Interventions

  • Ketamine1 mg/kg/h
    via IV• continuous infusion

    Racemic ketamine 1 mg/kg/h; max 120 mg/hour; concentration 50 mg/ml; infusion rate 0.02 ml/kg/h (max 2.4 ml/h); started within 6 hours after randomization.

Placebo infusion

active comparator

Normal saline infusion at same rate as ketamine.

Interventions

  • Placebo
    via IV• continuous infusion

    0.9% NaCl administered at 0.02 ml/kg/h (max 2.4 ml/h) matching ketamine infusion.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Traumatic brain injury patients
  • Age >= 18 years
  • Admitted to the ICU
  • Within 72 hours after admission to the initial hospital:
  • * ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
  • * Requiring sedation

Exclusion Criteria

  • 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 interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited
  • Therapy restriction code upon inclusion
  • Porphyria
  • Glaucoma

Study Details

Locations

Imelda Bonheiden — Bonheiden, Belgium
AZ Sint-Jan — Bruges, Belgium
Jessa Ziekenhuis — Hasselt, Belgium
UZLeuven — Leuven, Belgium
CHR de la Citadelle Liège — Liège, Belgium
CHU de Liège — Liège, Belgium
AZ Delta — Roeselare, Belgium
AZ Turnhout — Turnhout, Belgium

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