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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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12 December 2020 |
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Main ID: |
NCT03053869 |
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Date of registration:
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13/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free)
B-Free |
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Scientific title:
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Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free): A Two-centre Pilot Study to Determine the Feasibility of a Multi-centre, Randomized, Cluster Crossover Trial |
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Date of first enrolment:
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April 1, 2017 |
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Target sample size:
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480 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03053869 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Summer Syed, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University/Hamilton Health Sciences Corp. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients undergoing cardiac surgery during the study period at the Hamilton
General and St. Boniface General Hospitals.
Exclusion Criteria:
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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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Post-operative Delirium
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Intervention(s)
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Drug: Benzodiazepine - limited use strategy
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Drug: Benzodiazepine - Ad libitum strategy
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Primary Outcome(s)
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Completion of a minimum of at least 1 CAM assessment per day
[Time Frame: 1 day]
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Confusion Assessment Method (CAM) assessment
[Time Frame: 1 day]
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Protocol adherence
[Time Frame: 4-week crossover period]
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Secondary Outcome(s)
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In hospital mortality
[Time Frame: 1-14 days]
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Length of stay in Hospital
[Time Frame: 5-14 days]
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Delirium duration
[Time Frame: 5-7 days]
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Length of stay in the Intensive Care unit (ICU)
[Time Frame: 1-3 days]
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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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