Study on the Effects of Ketamine on Therapy Intensity and Brain Pressure in Patients with Traumatic Brain Injury

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What is this study about?

This clinical trial is focused on studying the effects of ketamine on patients with traumatic brain injury. Traumatic brain injury occurs when a sudden trauma causes damage to the brain, which can lead to various complications, including increased pressure inside the skull. The study aims to explore whether adding ketamine to the usual sedative treatment can help reduce the intensity of treatments needed to manage this pressure.

Participants in the study will receive either ketamine or a placebo as part of their treatment. Ketamine is administered as a solution for injection, specifically through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The study will monitor the effects of ketamine on the pressure inside the skull and the overall treatment intensity required for managing this pressure.

The trial will follow participants over a period of time to observe any changes in their condition, including the number of high-pressure episodes and the duration of sedative treatments. The study will also look at other factors such as the length of stay in the intensive care unit and the hospital, as well as the overall recovery outcomes six months after the brain injury. The goal is to determine if ketamine can make a significant difference in the treatment and recovery of patients with traumatic brain injury.

1 joining the study

Participation begins after admission to the Intensive Care Unit (ICU) with a diagnosis of traumatic brain injury.

Eligibility requires being 18 years or older and having an intracranial pressure (ICP) monitor in place within 72 hours of hospital admission.

2 treatment initiation

The treatment involves the administration of Ketalar 50 mg/ml solution through an intravenous infusion.

The purpose is to study the effects of ketamine on therapy intensity level and intracranial pressure.

3 monitoring and assessment

The primary goal is to observe a reduction in the cumulative daily Therapy Intensity Level (TIL) score and the number of high intracranial pressure episodes.

Secondary observations include average intracranial pressure per 24 hours, duration of sedative treatment, and length of stay in the ICU and hospital.

4 outcome evaluation

The study evaluates outcomes such as the Extended Glasgow Outcome Score (GOSE) at 6 months post-injury.

Other factors include delirium-free days, incidence of barbiturate coma, and incidence of decompressive craniectomy.

5 completion of study

The estimated end date for the trial is December 31, 2025.

The study aims to provide insights into the effectiveness of ketamine in managing intracranial pressure in brain injury patients.

Who Can Join the Study?

Must have a traumatic brain injury. This means an injury to the brain caused by an external force, like a fall or accident.
Must be 18 years or older.
Must be admitted to the Intensive Care Unit (ICU), which is a special department in the hospital for very sick patients who need close monitoring.
Must have an ICP monitor in place within 72 hours after being admitted to the first hospital. An ICP monitor is a device used to measure the pressure inside the skull. It can be a parenchymal probe, a ventricular catheter, or both.
Must require sedation, which means using medicine to help you relax or sleep.

Who Cannot Join the Study?

Patients who do not have a traumatic brain injury cannot participate. A traumatic brain injury is a type of injury to the brain caused by an external force, like a blow to the head.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Both male and female patients can participate, so gender is not a reason for exclusion.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Jessa Ziekenhuis	Hasselt	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
AZ Turnhout	Turnhout	Belgium
Izizkd	Bonheiden	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2021

Trial locations

Investigated drugs:

Ketamine

Ketamine is being studied in this trial to see if it can help reduce the intensity of treatments needed to control intracranial pressure in patients with acute brain injuries. It is being added to the usual sedative treatments to see if it can make managing brain pressure easier and more effective.

Traumatic Brain Injury – Traumatic brain injury (TBI) occurs when an external force injures the brain, often resulting from falls, vehicle accidents, or sports injuries. The severity of TBI can range from mild, with temporary symptoms, to severe, with long-lasting effects. Symptoms may include headaches, confusion, dizziness, memory problems, and changes in mood or behavior. As the injury progresses, individuals may experience increased intracranial pressure, which can lead to further complications. The condition can affect cognitive, physical, and emotional functions, depending on the extent and location of the injury. Recovery varies widely, with some individuals experiencing significant improvement over time, while others may have persistent challenges.

Trial ID:

2023-505319-19-00

Protocol code:

S60859

NCT ID:

NCT05097261

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Ketamine on Therapy Intensity and Brain Pressure in Patients with Traumatic Brain Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?