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: April 21, 2014
Last verified: April 2014

July 22, 2010
April 21, 2014
October 2009
November 2013   (final data collection date for primary outcome measure)
  • Reduction in variability of ICP [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Reduction in Pressure Reactivity Index [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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
Improved physiologic response in patients with secondary brain injury [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Including the following physiologic characteristics Adequate CPP MAP variability Sedative use Analgesic use Shivering
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
  • 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.
Not Provided

*   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 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169467
Pro00018317
No
Duke University
Duke University
Hospira, Inc.
Principal Investigator: Keith Dombrowski, MD Duke University
Duke University
April 2014

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