Ketamine in Severe Traumatic Brain Injury

StatusWithdrawn
PhaseEarly Phase 1
Started

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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: It was not possible to recruit any patients to this study as neurosurgery is placing external ventricular drains and nearly no intra-cranial pressure monitors. No patients recruited or approached. No data collected. Show 4 more changesShow less
    • Enrollment target: estimated 10 to confirmed 0
    • Primary endpoints: details revised at 1 of 2 entries
    • Study sites: 2 to 0
    • Eligibility criteria expanded, about 11 words
  2. Primary completion date: Jan 2026 to Dec 2026
    • Start date: Dec 1, 2025 to Jun 1, 2026
    • Study completion date: Nov 2026 to Jun 2027
    • Study arms: 0 to 1
    v6
  3. Start date: Mar 18, 2024 to Dec 1, 2025
    • Study sites: 1 to 2
    v5
  4. Site contact updatedv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 2024 to Jan 2026
    • Study completion date: Nov 2024 to Nov 2026
    • Start date changed from estimate of Feb 2024 to Mar 18, 2024
    v3
  6. Start date: Nov 2023 to Feb 2024
    • Primary endpoints revised (2)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06062628
Lead Sponsor University of Texas Southwestern Medical Center
Conditions
(from sponsor)		 Traumatic Brain Injury, Traumatic Encephalopathy
Related terms Brain Injuries, Traumatic
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov