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
Results First Received: November 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Endotracheal Intubation
Continuous IV Sedation
ICP Monitoring
Interventions: Drug: Standard-of-Care plus Dexmedetomidine
Other: Standard-of-Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
89 subject signed consent, 5 subjects screen failed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard-of-Care Plus Precedex Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
Standard-of-Care Subjects who are treated with the standard of care sedation regiment only.

Participant Flow:   Overall Study
    Standard-of-Care Plus Precedex     Standard-of-Care  
STARTED     44     40  
COMPLETED     37     36  
NOT COMPLETED     7     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard-of-Care Plus Precedex Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
Standard-of-Care Subjects who are treated with the standard of care sedation regiment only.
Total Total of all reporting groups

Baseline Measures
    Standard-of-Care Plus Precedex     Standard-of-Care     Total  
Number of Participants  
[units: participants]
  44     40     84  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     38     32     70  
>=65 years     6     8     14  
Gender  
[units: participants]
     
Female     17     13     30  
Male     27     27     54  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     1     3  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     10     15     25  
White     32     24     56  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     2     4  
Not Hispanic or Latino     42     38     80  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Variability of Intracranial Pressure (ICP)   [ Time Frame: Baseline to 24 hours ]

2.  Primary:   Change in Pressure Reactivity Index (PRx)   [ Time Frame: Baseline to 24 hours ]

3.  Secondary:   Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury   [ Time Frame: 24 hours ]

4.  Secondary:   Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury   [ Time Frame: Baseline to 24 hours ]

5.  Secondary:   Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury   [ Time Frame: Baseline to 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Keith Dombrowski
Organization: Duke University Medical Center
phone: (919)
e-mail: keith.dombrowski@dm.duke.edu


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