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Cerebral Perfusion Pressure Using Precedex and Other Sedatives (C3PO)

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Duke University

Status and phase

Completed
Phase 3

Conditions

Endotracheal Intubation
Continuous IV Sedation
ICP Monitoring

Treatments

Drug: Standard-of-Care plus Dexmedetomidine
Other: Standard-of-Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01169467
Pro00018317

Details and patient eligibility

About

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

Full 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.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

89 participants in 2 patient groups, including a placebo group

Standard-of-Care plus Precedex
Active Comparator group
Description:
Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.
Treatment:
Drug: Standard-of-Care plus Dexmedetomidine
Standard-of-Care
Placebo Comparator group
Description:
Subjects who are treated with the standard of care sedation regiment only.
Treatment:
Other: Standard-of-Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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