Ketamine in Severe Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062628
• Other study ID #: STU-2023-0805
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 18, 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Ketamine Hydrochloride
Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor)	Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury	3 hours
Primary	Brain tissue oxygenation (measured by intracranial oxygen probe)	Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury	3 hours