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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00242151
Other study ID # UHN REB 05-0223-AE
Secondary ID
Status Recruiting
Phase N/A
First received October 18, 2005
Last updated October 11, 2006

Study information

Verified date September 2006
Source University Health Network, Toronto
Contact Jo A Carroll, RN
Phone 416-340-4800
Email jo.carroll@uhn.on.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- All patients undergoing cardiac surgery in our institute in 2 year period

- Signed informed consent

Exclusion criteria:

- 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Toronto General Hospital, University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

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