Safety of Dexmedetomidine in Severe Traumatic Brain Injury

NCT01007773 | Withdrawn Phase 2 DMC

• 2 other identifiers: HP-00042821PRE-08-019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Dexmedetomidine; Intracranial Pressure; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Intracranial pressure

  one week

Secondary Outcomes (3)

• Doses of other sedatives

  one week

• Mortality

  6 months

• GOS-E

  12 weeks, 6 months

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

In conjunction with conventional sedative and analgesic agents.

Drug: Precedex; Drug: Propofol

Standard of Care

ACTIVE COMPARATOR

Patients randomized to conventional sedation will have as the main pharmacologic agents to achieve sedation and analgesia propofol and fentanyl, respectively.

Drug: Propofol; Drug: Fentanyl

Interventions

Precedex DRUG

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.

Also known as: Dexmedetomidine

Dexmedetomidine

Propofol DRUG

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.

Also known as: Diprivan

Standard of Care

Fentanyl DRUG

Fentanyl will be initiated and titrated to achieve adequate pain control.

Also known as: Actiq, Fentora, Instanyl

Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dexmedetomidine; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines

Study Officials

• Deborah Stein, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurotrauma Critical Care; Chief, Section of Trauma Critical Care, R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 4, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)