NCT01169467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

4.1 years

First QC Date

July 22, 2010

Results QC Date

November 5, 2014

Last Update Submit

October 6, 2015

Conditions

Endotracheal IntubationContinuous IV SedationICP Monitoring

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

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

    24 hours

  • Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury

    Baseline to 24 hours

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

    Baseline to 24 hours

Study Arms (2)

Standard-of-Care plus Precedex

ACTIVE COMPARATOR

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

Drug: Standard-of-Care plus Dexmedetomidine

Standard-of-Care

PLACEBO COMPARATOR

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

Other: Standard-of-Care

Interventions

Standard-of-Care plus DexmedetomidineDRUG

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

Also known as: Precedex
Standard-of-Care plus Precedex
Standard-of-CareOTHER

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

Standard-of-Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

    PMID: 24506248BACKGROUND

MeSH Terms

Interventions

Standard of CareDexmedetomidine

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Keith Dombrowski
Organization
Duke University Medical Center
keith.dombrowski@dm.duke.edu
(919)

Study Officials

  • Keith Dombrowski, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 26, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 2, 2015

Results First Posted

November 2, 2015

Record last verified: 2015-10

Locations

US(1)