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Cerebral Perfusion Pressure Using Precedex and Other Sedatives (C3PO)

This study is currently recruiting participants.
Verified February 2013 by Duke University
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01169467
First received: July 22, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.


Condition Intervention Phase
Endotracheal Intubation
Continuous IV Sedation
ICP Monitoring
 Drug: Standard-of-Care plus Dexmedetomidine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cerebro-vascular Pressure Reactivity Index [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard-of-Care plus Precedex
Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.
 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
Placebo Comparator: Standard-of-Care
Subjects who are treated with the standard of care sedation regiment only.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169467

Contacts
Contact: Keith Dombrowski, MD (919) 684-8246 keith.dombrowski@dm.duke.edu
Contact: Kristina Riemen (919) 684-0071 kristina.riemen@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Keith Dombrowski, MD     919-684-8246     keith.dombrowski@dm.duke.edu    
Contact: Kristina Riemen     (919) 684-0071     kristina.riemen@duke.edu    
Principal Investigator: Keith Dombrowski, MD            
Sponsors and Collaborators
Duke University
Hospira, Inc.
Investigators
Principal Investigator: Keith Dombrowski, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01169467     History of Changes
Other Study ID Numbers: Pro00018317
Study First Received: July 22, 2010
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypnotics and Sedatives
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013