Clinical trial
Safety of Dexmedetomidine in Severe Traumatic Brain Injury
Name
HP-00042821
Description
The aim of this study is to assess the safety and feasibility of dexmedetomidine as an adjunct to conventional sedative therapy compared to conventional sedative therapy alone in patients with severe traumatic brain injury.
Trial arms
Trial start
2010-01-01
Estimated PCD
2011-01-01
Trial end
2012-01-01
Status
Withdrawn
Phase
Early phase I
Treatment
Precedex
Once this patient is deemed stable on the propofol infusion, the patient will be started on a dexmedetomidine infusion at 0.4 mcg/kg/hr. The dexmedetomidine infusion will be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -1 (maximum rate of 1.5 mcg/kg/hr). In the meantime, once sustained ICP control has been achieved, the initial sedative agent (usually propofol) will be weaned. Dexmedetomidine will be infused for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued. When the patient is ready to come off sedation, the dexmedetomidine will be weaned by 50% every hour over a 4-hour period to off.
Arms:
Dexmedetomidine
Other names:
Dexmedetomidine
Propofol
Propofol will be initiated at 25 mcg/kg/min and titrated to achieve an ICP \< 20 mm Hg (up to a maximum of 75 mcg/kg/min). Propofol will be continued for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued.
Arms:
Standard of Care
Other names:
Diprivan
Fentanyl
Fentanyl will be initiated and titrated to achieve adequate pain control.
Arms:
Standard of Care
Other names:
Actiq, Fentora, Instanyl
Propofol
Propofol will be titrated to an ICP \< 20 mm Hg until achievement of sustained ICP control.
Arms:
Dexmedetomidine
Other names:
Diprivan
Primary endpoint
Intracranial pressure
one week
Eligibility criteria
Inclusion Criteria:
* Diagnosis of severe traumatic brain injury, as defined by AIS score \>2 for the head.
* Glasgow Coma Score (GCS) \<9 on admission, or deterioration of GCS to \<9 within 48 hours of admission due to traumatic brain injury.
* Placement of an intracranial pressure (ICP) monitor or intraventricular catheter (IVC) at the discretion of the Neurosurgical staff as part of standard of care.
* Patient is between 18 and 80 years of age, inclusive.
Exclusion Criteria:
* A body region, other than the brain, with an AIS score \>2, or multiple system injury at the investigator's discretion.
* Glasgow Coma Score (GCS) \>8 on admission or no decrease of GCS to \<9 within 48 hours of admission.
* Placement of an ICP monitor or IVC not clinically indicated by Neurosurgical staff.
* Patient is under the age of 18, or over the age of 80.
* Determination of non-survivability due to the severity of brain injury.
* Non-English speaking, consentable LAR, or patient is non-English speaking.
* Patient is pregnant.
* Unable to obtain consent from a legally authorized representative (LAR).
* Patient is a prisoner, on parole or probation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-09-13
1 organization
3 products
1 indication
Organization
University of Maryland, BaltimoreProduct
PrecedexIndication
Traumatic Brain InjuryProduct
PropofolProduct
Fentanyl