Ketamine in Severe Traumatic Brain Injury

NCT06062628 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STU-2023-0805
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury; Traumatic Encephalopathy

Keywords

ketamine; traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Ketamine Intervention Arm

EXPERIMENTAL

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.

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

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

Ketamine Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anna Bashmakov, D.O.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology - Neuro Critical Care Fellow

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)