Ignite Creation Date:
2024-05-05 @ 9:59 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01007773
Status:
WITHDRAWN
Last Update Posted:
2023-09-13
First Post:
2009-11-02
Brief Title:
Safety of Dexmedetomidine in Severe Traumatic Brain Injury
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Safety of Dexmedetomidine in Severe Traumatic Brain Injury
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study will not be intiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 52000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRE-08-019 | None | None | None |