RECRUITINGPhase 4INTERVENTIONAL

Ketamine in Acute Brain Injury Patients.

Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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: * 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

Treatments Being Tested

DRUG

Ketamine

Racemic 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.

DRUG

Placebo

Placebo (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).

Locations (8)

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