Clinical trial NCT06429657: Ketamine for Sedation in Severe Traumatic Brain Injury
Official title: Ketamine for Sedation in Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Severe Traumatic Brain Injury
Intracranial Hypertension
Intracranial Hemorrhage, Hypertensive
Keywords: TBI
Severe TBI
Traumatic Brain Injury
Sedation
Ketamine
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: Brooke Army Medical Center
First posted: 2024-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

Detailed description: Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm.

Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes (coughing etc.). In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will be continued until removal of intracranial pressure monitoring.

This study will take place during the participant's hospital care. The clinical team will administer treatment using standard practices, including all safety precautions available. Side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk.

The research team will performed one outpatient follow-up after study intervention ends.

Eligibility criteria: Inclusion Criteria:

* Adults 18-65 years of age
* Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
* Placement of intracranial pressure monitor
* Receiving treatment in an intensive care unit (ICU)

Exclusion Criteria:

* Significant cardiovascular disease with recent coronary intervention
* Pregnancy
* Prisoners
* Known allergy to ketamine or propofol

Primary outcomes:
measure: Number of ICP elevations greater than 22 mmHg for greater than 5 minutes
timeFrame: During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting
measure: Mean ICP
timeFrame: During the maximum 5-day course of study intervention.
Secondary outcomes:
measure: Total time spent with intracranial pressure (ICP) >22 mmHg
timeFrame: During the maximum 5-day course of study intervention.
measure: Mean Cerebral Perfusion Pressure (CPP)
timeFrame: During the maximum 5-day course of study intervention.
measure: Total time spent with CPP <60 mmHg
timeFrame: During the maximum 5-day course of study intervention.
measure: Total number of events where CPP <60 mmHg for greater than 5 minutes
timeFrame: During the maximum 5-day course of study intervention.
measure: Vasopressor dependency index (VDI)
timeFrame: During the maximum 5-day course of study intervention.
measure: Incidence of seizures
timeFrame: During the maximum 5-day course of study intervention.
measure: Incidence of cardiac arrhythmias
timeFrame: During the maximum 5-day course of study intervention.
measure: Mean heart rate
timeFrame: During the maximum 5-day course of study intervention.
measure: Incidence of post-traumatic stress disorder (PTSD) in outpatient setting
timeFrame: Outpatient follow-up six months after intervention.
measure: Glasgow Coma Outcome Scale extended (GOSE-TBI) scores
timeFrame: Outpatient follow-up six months after intervention.
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Bradley Dengler, MD
role: PRINCIPAL_INVESTIGATOR
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