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Trial record 1 of 1 for:    NCT01007773
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Safety of Dexmedetomidine in Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01007773
Recruitment Status : Withdrawn (Study will not be intiated)
First Posted : November 4, 2009
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Deborah Stein, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE November 2, 2009
First Posted Date  ICMJE November 4, 2009
Last Update Posted Date November 5, 2019
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
Intracranial pressure [ Time Frame: one week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
  • Doses of other sedatives [ Time Frame: one week ]
  • Mortality [ Time Frame: 6 months ]
  • GOS-E [ Time Frame: 12 weeks, 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
  • Doses of other sedatives [ Time Frame: one week ]
  • Mortality [ Time Frame: 1 year ]
  • GOS-E [ Time Frame: 3 months, 6 months, one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Dexmedetomidine in Severe Traumatic Brain Injury
Official Title  ICMJE Safety of Dexmedetomidine in Severe Traumatic Brain Injury
Brief Summary 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.
Detailed Description

Approximately 52,000 deaths occur from traumatic brain injury (TBI) every year. TBI is a major cause of disability, death, and economic cost to our society. When the brain experiences injury, there is direct damage to the brain tissue causing local bleeding and bruising. This is called the primary injury. Additional damage, called secondary brain injury, can occur as a result of swelling of the brain, lack of oxygen to the brain, lowered blood pressure, and the release of inflammatory mediators. The type and degree of insults are major determinants in the final neurologic outcome of the patient who has sustained a TBI. Management of TBI is aimed at the prevention and treatment of these secondary insults.

The swelling of the brain following injury causes an increase in the pressure within the cranium. Increased pressure can reduce blood flow to parts of the brain, leading to further brain damage. An intracranial pressure (ICP) monitor measures the pressure surrounding the brain, and may be placed following traumatic brain injury to help evaluate swelling.

Agitation of the patient or exposure to painful stimuli may significantly increase ICP, and therefore, the use of sedative agents is important in ICP management. A variety of pharmacological agents have been suggested to treat agitation in the TBI patient. Unfortunately, no optimal sedative regimen has been identified for use in this patient population. One prospect is dexmedetomidine (Precedex®), which is FDA-approved for short-term (≤24 hours) sedation in the intensive care unit. Currently, to our knowledge, dexmedetomidine has not been studied prospectively in adults with traumatic brain injury. The safety and efficacy of dexmedetomidine are therefore unknown in severe TBI. Propofol is employed as a first-line sedative agent in neurotrauma patients due to its favorable pharmacokinetic profile. However, some patients require prolonged infusions and high rates of propofol. This has been shown increase their risk for development of a severe propofol-related infusion syndrome, which can be fatal.

Dexmedetomidine as an adjunct to existing conventional sedative therapy may help to facilitate decreasing the amount of other agents used, such as propofol. Therefore, 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 TBI.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: 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.
    Other Name: Dexmedetomidine
  • Drug: 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.
    Other Name: Diprivan
  • Drug: Fentanyl
    Fentanyl will be initiated and titrated to achieve adequate pain control.
    Other Names:
    • Actiq
    • Fentora
    • Instanyl
  • Drug: Propofol
    Propofol will be titrated to an ICP < 20 mm Hg until achievement of sustained ICP control.
    Other Name: Diprivan
Study Arms  ICMJE
  • Experimental: Dexmedetomidine
    In conjunction with conventional sedative and analgesic agents.
    Interventions:
    • Drug: Precedex
    • Drug: Propofol
  • Active Comparator: Standard of Care
    Patients randomized to conventional sedation will have as the main pharmacologic agents to achieve sedation and analgesia propofol and fentanyl, respectively.
    Interventions:
    • Drug: Propofol
    • Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2009)
40
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01007773
Other Study ID Numbers  ICMJE HP-00042821
PRE-08-019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deborah Stein, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Deborah Stein, MD University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP