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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02548975 |
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Date of registration:
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04/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Risk Factors for Delirium Following Cardiac Surgery
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Scientific title:
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Risk Factors for Delirium Following Cardiac Surgery |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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5600 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02548975 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Contacts
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Name:
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Jason O'Neal, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients undergoing elective cardiac surgery (coronary artery bypass grafting (CABG),
CABG+valve(s), valve only)
*depending on the study - OR aortic valve replacement (will include patients undergoing
transcatheter aortic valve replacement (TAVR) and patients undergoing only aortic valve
replacement with CPB)
Exclusion Criteria:
Emergency cases will be excluded.
*depending on the study - Patients undergoing any valve replacement surgery other than
aortic valve
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Delirium
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Intervention(s)
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Drug: Statin, beta blocker
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Other: Cardiopulmonary bypass
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Primary Outcome(s)
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Incidence of delirium
[Time Frame: During ICU stay, average may be 4 days]
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Secondary Outcome(s)
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Days in ICU
[Time Frame: During ICU stay, average may be 4 days]
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Acute kidney injury
[Time Frame: During hospital stay, average may be 1 week]
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Total length of stay
[Time Frame: During hospital stay, average may be 1 week]
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Duration of delirium
[Time Frame: During ICU stay, average may be 4 days]
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Atrial fibrillation
[Time Frame: During hospital stay, average may be 1 week]
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In hospital and 30 day mortality
[Time Frame: During hospital admission and within 30 days of surgery]
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Secondary ID(s)
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123456789
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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