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Completed

NCT Number: NCT01169467

Cerebral Perfusion Pressure Using Precedex and Other Sedatives

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

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Key information

Conditions

Endotracheal Intubation Continuous IV Sedation ICP Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard-of-Care plus Dexmedetomidine

Drug

Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment

Other names: Precedex

Standard-of-care

Other

Subjects who are treated with the standard of care sedation regiment only.

Primary outcomes

  1. Variability of Intracranial Pressure (ICP)

    Time frame: 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

  2. Change in Pressure Reactivity Index (PRx)

    Time frame: 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 outcomes

  1. Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury

    Time frame: 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.

  2. Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury

    Time frame: 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.

  3. Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Acronym: C3PO

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2010
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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