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
  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
Other: Standard-of-Care
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:
  • 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.



Secondary Outcome Measures:
  • 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.


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.
Other: 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01169467     History of Changes
Other Study ID Numbers: Pro00018317 
Study First Received: July 22, 2010
Results First Received: November 5, 2014
Last Updated: October 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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 August 22, 2016