Clinical TrialTraumatic Brain Injury (TBI)KetaminePlaceboActive not recruiting

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.

Randomised, double-blind, placebo-controlled trial (n=100) in Belgium assessing adjunctive IV ketamine (Ketalar) versus placebo to reduce Therapy Intensity Level (TIL) and monitor intracranial pressure (ICP) in acute traumatic brain injury patients.

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

Detailed Description

A multicentre, randomised, double-blind, placebo-controlled EEA CTA (EudraCT 2017-004698-15) evaluating whether adding intravenous ketamine to sedation regimens reduces cumulative daily Therapy Intensity Level in adults with traumatic brain injury and an ICP monitor in place.

Primary efficacy endpoint is reduction in daily TIL score; primary safety endpoint is the number of high intracranial pressure episodes (ICP >22 mmHg for >20 minutes). Secondary outcomes include mean ICP, duration of ventilation and sedation, sedative doses, ICU and hospital length of stay, delirium metrics and functional outcome (GOSE at 6 months).

Study Arms & Interventions

Ketamine

experimental

Intravenous ketamine infusion (marketed Ketalar) used adjunctively to sedative regimen for ICP control.

Interventions

  • Ketamine
    via IV• as per protocol

    Ketalar (ketamine hydrochloride) solution for injection/infusion; concentration described as 50 mg/ml in protocol; dosing per local protocol.

Placebo

inactive

Placebo infusion matching ketamine vehicle.

Interventions

  • Placebo
    via IV• as per protocol

    Placebo solution for infusion matching active arm.

Participants

Ages
18 – 95
Sexes
Male & Female

Inclusion Criteria

  • Traumatic brain injury patients requiring sedation and ICP control
  • Age ≥ 18 years
  • Admitted to the ICU
  • 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 or congenital/non-congenital brain dysfunction
  • Inability to obtain informed consent
  • Inclusion in an IMP-RCT that specifically prohibits co-inclusion
  • Therapy restriction code upon inclusion
  • Porphyria
  • Glaucoma

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment100 participants
  • Timeline
    Start: 2020-10-30
    End: 2024-12-31
  • Compounds
    KetaminePlacebo
  • Topic
    Traumatic Brain Injury (TBI)

Locations

Belgium

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