NCT00242151

Brief Summary

The objective of this study is to determine prevalence of postoperative delirium and confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to evaluate effect of cardiac surgery on prevalence of delirium and confusion. The primary aim is to evaluate prevalence of delirium and confusion in patients undergoing cardiac surgery and to determine risk factors for this condition. A secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion. The hypothesis to be tested is that patients with postoperative delirium and confusion have high incidence of organic brain injury as detected by DW-MRI.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

October 12, 2006

Status Verified

September 1, 2006

First QC Date

October 18, 2005

Last Update Submit

October 11, 2006

Conditions

Keywords

Delirium, Confusion, Cardiac Surgery, Organic Brain Injury, Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing cardiac surgery in our institute in 2 year period
  • Signed informed consent

You may not qualify if:

  • Past history of transient ischemic attacks, stroke, symptomatic carotid artery disease.
  • Past history of psychiatric disorders
  • History of alcohol and drug abuse
  • History of severe kidney or liver disease (creatinine \>2.5mg/dL and bilirubin \> 2mg/dL)
  • Known contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Heart DiseasesDeliriumConfusion

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Rita Katznelson, MD

    Toronto General Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo A Carroll, RN

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Last Updated

October 12, 2006

Record last verified: 2006-09

Locations