Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Phase 3

Completed

• Conditions: Endotracheal Intubation; ICP Monitoring; Continuous IV Sedation
• Interventions: Drug: Standard-of-Care plus Dexmedetomidine; Other: Standard-of-Care

• Registration Number: NCT01169467
• Lead Sponsor: Duke University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-26
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2014-11-05
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Results First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	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	Standard-of-Care	Subjects who are treated with the standard of care sedation regiment only.

Primary Outcome Measures

Name	Time	Method
Variability of Intracranial Pressure (ICP)	Baseline to 24 hours	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)	Baseline to 24 hours	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

Name	Time	Method
Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury	Baseline to 24 hours	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.
Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury	24 hours	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.
Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury	Baseline to 24 hours	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States