Ketamine in Severe Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2027-06-30

Brief Summary

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Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.

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Detailed Description

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Conditions

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Traumatic Brain Injury Traumatic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine Intervention Arm

A single dose of 0.5 mg/kg (actual body weight) of ketamine will be administered intravenously. Ketamine will be administered in addition to the patient's existing analgesia, sedation and other medicines as a part of their routine treatment.

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

Interventions

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Ketamine Hydrochloride

Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe traumatic brain injury
* Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation
* Age greater than or equal to 18 years

Exclusion Criteria

* Documented allergy to ketamine
* Sinus tachycardia with sustained heart rate \>120
* Any episode of non-sinus tachycardia
* Documented history of schizophrenia
* Systolic blood pressure \> 180, diastolic blood pressure \> 120
* Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours
* Similar episodes as above of PbtO2 \<15 mmHg
* Positive pregnancy test and/or is currently breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No