Cerebral Perfusion Pressure Using Precedex and Other Sedatives

NCT01169467

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endotracheal Intubation, Continuous IV Sedation, ICP Monitoring
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Admitted to Duke University Neuro Critical Care Unit (NCCU)

- Adult (18 years of age or older)

- Expected Mechanical Ventilation for >48 hours with sedation

- Intraventricular catheter in situ

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Hypersensitivity to study drugs


- Prisoners


- Moribund state or death expected within 24 hours


- Surgery planned within 24 hours of subject enrollment


- Receiving study drug, Precedex, prior to entering study

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Endotracheal Intubation, Continuous IV Sedation, ICP MonitoringCerebral Perfusion Pressure Using Precedex and Other Sedatives
NCT01169467
  1. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Official Title  ICMJE Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Brief Summary The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Detailed Description

Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Endotracheal Intubation
  • Continuous IV Sedation
  • ICP Monitoring
Intervention  ICMJE
  • Drug: Standard-of-Care plus Dexmedetomidine
    Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
    Other Name: Precedex
  • Other: Standard-of-Care
    Subjects who are treated with the standard of care sedation regiment only.
Study Arms  ICMJE
  • Active Comparator: Standard-of-Care plus Precedex
    Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.
    Intervention: Drug: Standard-of-Care plus Dexmedetomidine
  • Placebo Comparator: Standard-of-Care
    Subjects who are treated with the standard of care sedation regiment only.
    Intervention: Other: Standard-of-Care
Publications * Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2013)
89
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
100
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Admitted to Duke University Neuro Critical Care Unit (NCCU)
  • Adult (18 years of age or older)
  • Expected Mechanical Ventilation for >48 hours with sedation
  • Intraventricular catheter in situ

Exclusion Criteria:

  • Hypersensitivity to study drugs
  • Prisoners
  • Moribund state or death expected within 24 hours
  • Surgery planned within 24 hours of subject enrollment
  • Receiving study drug, Precedex, prior to entering study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT01169467
Other Study ID Numbers  ICMJE Pro00018317
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Keith Dombrowski, MDDuke University
PRS Account Duke University
Verification Date October 2015

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