Heart DiseaseNCT00242151
Prevalence of Delirium in Patients Undergoing Cardiac Surgery
An observational study of Heart Disease, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing cardiac surgery in our institute in 2 year period
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Jo A Carroll, RN, 416-340-4800 ext. 3243, jo.carroll@uhn.on.ca
George N Djaiani, MD
About this study
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.
Read more
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.
- Conditions
- Heart Disease
- Keywords
- Delirium, Confusion, Cardiac Surgery, Organic Brain Injury, Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)
- Medical subject headings
- Heart Diseases, Delirium, Confusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Rita Katznelson, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242151
- Sponsor's protocol ID
- UHN REB 05-0223-AE
- Status last verified
- Sep 2006
- First submitted
- 18 Oct 2005
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Delirium in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00242151
- Acronym / sponsor ID
- UHN REB 05-0223-AE
- Conditions
- Heart Disease
- Keywords
- Delirium, Confusion, Cardiac Surgery, Organic Brain Injury, Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing cardiac surgery in our institute in 2 year period
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Katznelson, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jo A Carroll, RN (416-340-4800 ext. 3243, jo.carroll@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2006.