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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02603731 |
Date of registration:
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04/11/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Delirium at the Intensive Care Unit - a Retrospective Cohort Study
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Scientific title:
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Delirium at the Intensive Care Unit - a Retrospective Cohort Study |
Date of first enrolment:
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August 2015 |
Target sample size:
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183 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02603731 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Ole Mathiesen, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Køge Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients >18 years of age admitted to the ICU at Køge Hospital in the study period
Exclusion Criteria:
- Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period
- No CAM-ICU scores during the ICU stay
- Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain
damage)
- Severe dementia documented in electronic patient charts (OPUS)
- Patients not receiving active treatment (moribund patients)
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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Intensive Care Unit Syndrome
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Delirium
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Primary Outcome(s)
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Delirium at any time point
[Time Frame: Throughout study period, up to 6 months]
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Secondary Outcome(s)
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Days with delirium
[Time Frame: Throughout study period, up to 6 months]
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Delirium and Simplified Acute Physiology Score (SAPS)
[Time Frame: Throughout study period, up to 6 months]
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Mortality
[Time Frame: Throughout study period, up to 6 months]
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Circadian light exposure
[Time Frame: Throughout study period, up to 6 months]
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Demographic differences
[Time Frame: Throughout study period, up to 6 months]
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Delirium in patients treated with steroids
[Time Frame: Throughout study period, up to 6 months]
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Delirium in patients treated with hypnotics
[Time Frame: Throughout study period, up to 6 months]
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Delirium related to number of ventilator days
[Time Frame: Throughout study period, up to 6 months]
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Delirium related to sedation
[Time Frame: Throughout study period, up to 6 months]
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Distribution of types of delirium
[Time Frame: Throughout study period, up to 6 months]
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Delirium related to admission type
[Time Frame: Throughout study period, up to 6 months]
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Secondary ID(s)
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SE-DELIR1-15
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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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