Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Endotracheal Intubation Clinical Trial

— C3PO  

Official title:

Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169467
• Other study ID #: Pro00018317
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2010
• Last updated: October 6, 2015
• Start date: October 2009
• Est. completion date: November 2013

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Continuous IV Sedation
• Endotracheal Intubation
• ICP Monitoring

Intervention

Drug:
• Standard-of-Care plus Dexmedetomidine
Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment

Other:
• Standard-of-Care
Subjects who are treated with the standard of care sedation regiment only.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Hospira, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of Intracranial Pressure (ICP)	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	Baseline to 24 hours	No
Primary	Change in Pressure Reactivity Index (PRx)	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.	Baseline to 24 hours	No
Secondary	Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury	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.	24 hours	No
Secondary	Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury	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.	Baseline to 24 hours	No
Secondary	Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury	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.	Baseline to 24 hours	No