Ketamine for Sedation in Severe Traumatic Brain Injury

Intracranial Hypertension Clinical Trial

— Ketamine  

Official title:

Ketamine for Sedation in Severe Traumatic Brain Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429657
• Other study ID #: C.2024.025
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Marisa F Rodriguez
• Phone: 210-851-5779
• Email: marisa.rodriguez.ctr[@]usuhs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Intracranial Hemorrhages
• Intracranial Hypertension
• Severe Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Ketamine with propofol
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

Other:
• Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam administered according to the institutional SOC guidelines.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Brooke Army Medical Center, Uniformed Services University of the Health Sciences

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean ICP	Mean ICP	During the maximum 5-day course of study intervention.
Secondary	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.
Secondary	Mean Cerebral Perfusion Pressure (CPP)	Mean CPP (in minutes).	During the maximum 5-day course of study intervention.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Incidence of seizures	Incidence of seizures (as documented by EEG).	During the maximum 5-day course of study intervention.
Secondary	Incidence of cardiac arrhythmias	Incidence of cardiac arrhythmias (other than sinus tachycardia).	During the maximum 5-day course of study intervention.
Secondary	Mean heart rate	Mean heart rate (HR).	During the maximum 5-day course of study intervention.
Secondary	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.
Secondary	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.