Cerebral Perfusion Pressure Using Precedex and Other Sedatives (C3PO)

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01169467
First received: July 22, 2010
Last updated: October 6, 2015
Last verified: October 2015

July 22, 2010
October 6, 2015
October 2009
November 2013   (final data collection date for primary outcome measure)
  • Variability of Intracranial Pressure (ICP) [ Time Frame: Baseline to 24 hours ] [ Designated as safety issue: No ]
    Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
  • Change in Pressure Reactivity Index (PRx) [ Time Frame: Baseline to 24 hours ] [ Designated as safety issue: No ]

    Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).

    A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.

Cerebro-vascular Pressure Reactivity Index [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01169467 on ClinicalTrials.gov Archive Site
  • Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.
  • Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury [ Time Frame: Baseline to 24 hours ] [ Designated as safety issue: No ]
    Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.
  • Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury [ Time Frame: Baseline to 24 hours ] [ Designated as safety issue: No ]
    Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.
Not Provided
Not Provided
Not Provided
 
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Endotracheal Intubation
  • Continuous IV Sedation
  • ICP Monitoring
  • 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.
  • 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
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.
 
Completed
89
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169467
Pro00018317
No
Not Provided
Not Provided
Duke University
Duke University
Hospira, Inc.
Principal Investigator: Keith Dombrowski, MD Duke University
Duke University
October 2015

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