Cerebral Perfusion Pressure Using Precedex and Other Sedatives (C3PO)

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 Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Continuous IV Sedation; ICP Monitoring
• Intervention / Treatment: Drug: Standard-of-Care plus Dexmedetomidine; Other: Standard-of-Care

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Keith Dombrowski, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 26, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Pro00018317