Expired Study
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Durham, North Carolina 27710


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.


Study summary:

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.


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


Study is Available At:


Original ID:

Pro00018317


NCT ID:

NCT01169467


Secondary ID:


Study Acronym:

C3PO


Brief Title:

Cerebral Perfusion Pressure Using Precedex and Other Sedatives


Official Title:

Cerebral Perfusion Pressure Using Precedex and Other Sedatives


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: P


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

89


Enrollment Type:

Actual


Overall Contact Information

Official Name:Keith Dombrowski, MD
Principal Investigator
Duke University

Study Dates

Start Date:October 2009
Completion Date:November 2013
Completion Type:Actual
Primary Completion Date:November 2013
Primary Completion Type:Actual
Verification Date:April 2014
Last Changed Date:April 21, 2014
First Received Date:July 22, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improved physiologic response in patients with secondary brain injury
Time Frame:24 hours
Safety Issues:False
Description:Including the following physiologic characteristics Adequate CPP MAP variability Sedative use Analgesic use Shivering
Outcome Type:Primary Outcome
Measure:Reduction in Pressure Reactivity Index
Time Frame:24 hours
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction in variability of ICP
Time Frame:24 hours
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Standard-of-Care plus Dexmedetomidine
Description:Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
Arm Name:Standard-of-Care plus Precedex
Other Name:Precedex

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Standard-of-Care
Description:Subjects who are treated with the standard of care sedation regiment only.
Study Arm Type:Active Comparator
Arm Name:Standard-of-Care plus Precedex
Description:Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Hospira, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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