Clinical trial NCT06062628: Ketamine in Severe Traumatic Brain Injury
Official title: Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Traumatic Brain Injury
Traumatic Encephalopathy
Keywords: ketamine
traumatic brain injury
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor)
timeFrame: 3 hours
measure: Brain tissue oxygenation (measured by intracranial oxygen probe)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Anna Bashmakov, D.O.
role: PRINCIPAL_INVESTIGATOR
References: