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
  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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 89
Study Start Date: October 2009
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
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: April 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014