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administrative hold at current open site and awaiting site startup at additional participating sites
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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
| Brooke Army Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine with propofol | Experimental | 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 |
|
| SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam | Active Comparator | Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine with propofol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ICP elevations greater than 22 mmHg for greater than 5 minutes | ICP elevations > 22 mmHg for greater than 5 minutes. | During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting |
| Mean ICP | Mean ICP | During the maximum 5-day course of study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Total time spent with intracranial pressure (ICP) >22 mmHg | Total time spent with ICP >22 mmHg (in minutes). | During the maximum 5-day course of study intervention. |
| Mean Cerebral Perfusion Pressure (CPP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Dengler, MD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30182649 | Background | Iaccarino C, Carretta A, Nicolosi F, Morselli C. Epidemiology of severe traumatic brain injury. J Neurosurg Sci. 2018 Oct;62(5):535-541. doi: 10.23736/S0390-5616.18.04532-0. | |
| 26414629 | Background | Agrawal D, Raghavendran K, Schaubel DE, Mishra MC, Rajajee V. A Propensity Score Analysis of the Impact of Invasive Intracranial Pressure Monitoring on Outcomes after Severe Traumatic Brain Injury. J Neurotrauma. 2016 May 1;33(9):853-8. doi: 10.1089/neu.2015.4015. Epub 2015 Oct 8. |
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| Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam | Other | Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam administered according to the institutional SOC guidelines. |
|
Mean CPP (in minutes).
| During the maximum 5-day course of study intervention. |
| Total time spent with CPP <60 mmHg | Total time spent with CPP <60 mmHg (in minutes). | During the maximum 5-day course of study intervention. |
| Total number of events where CPP <60 mmHg for greater than 5 minutes | Total number of events where CPP <60 mmHg (in minutes) for greater than 5 minutes. | During the maximum 5-day course of study intervention. |
| Vasopressor dependency index (VDI) | Relationship between vasopressor infusion dose and mean arterial blood pressure. VDI= (dobutamine dose × 1) + (dopamine dose × 1) + (norepinephrine dose × 100) + (vasopressin × 100) + (epinephrine × 100))/MAP indicating the relationship of high VDI and poor outcome. | During the maximum 5-day course of study intervention. |
| Incidence of seizures | Incidence of seizures (as documented by EEG). | During the maximum 5-day course of study intervention. |
| Incidence of cardiac arrhythmias | Incidence of cardiac arrhythmias (other than sinus tachycardia). | During the maximum 5-day course of study intervention. |
| Mean heart rate | Mean heart rate (HR). | During the maximum 5-day course of study intervention. |
| Incidence of post-traumatic stress disorder (PTSD) in outpatient setting | Incidence of PTSD at 6-month outpatient follow-up. | Outpatient follow-up six months after intervention. |
| Glasgow Coma Outcome Scale extended (GOSE-TBI) scores | GOSE-TBI assessment resulting in subjective measure of 0-8 regarding recovery after injury with higher score indicating greatest recovery to pre-injury life, will be conducted at 6-month outpatient follow-up. | Outpatient follow-up six months after intervention. |
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| Background | Military Health System and Defense Health Agency. DOD TBI Worldwide Numbers: Traumatic Brain Injury Center of Excellence; 2022 [Available from: https://health.mil/Military-Health-Topics/Centers-of-Excellence/Traumatic-Brain-Injury-Center-of-Excellence/DOD-TBI-Worldwide-NumbersTraumaticBrain]. |
| Background | Michalczyk, Lukasz, and Lukasz Kaczmarek. |
| Background | Chan, Kai En, et al. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D019586 | Intracranial Hypertension |
| D020299 | Intracranial Hemorrhage, Hypertensive |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| D004091 | Hydromorphone |
| D008874 | Midazolam |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D001570 | Benzodiazepinones |
Not provided
Not provided