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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02603731
Date of registration: 04/11/2015
Prospective Registration: No
Primary sponsor: Zealand University Hospital
Public title: Delirium at the Intensive Care Unit - a Retrospective Cohort Study
Scientific title: Delirium at the Intensive Care Unit - a Retrospective Cohort Study
Date of first enrolment: August 2015
Target sample size: 183
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02603731
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Denmark
Contacts
Name:     Ole Mathiesen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Køge Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Intensive Care Unit Syndrome
Delirium
Intervention(s)
Primary Outcome(s)
Delirium at any time point [Time Frame: Throughout study period, up to 6 months]
Secondary Outcome(s)
Days with delirium [Time Frame: Throughout study period, up to 6 months]
Delirium and Simplified Acute Physiology Score (SAPS) [Time Frame: Throughout study period, up to 6 months]
Mortality [Time Frame: Throughout study period, up to 6 months]
Circadian light exposure [Time Frame: Throughout study period, up to 6 months]
Demographic differences [Time Frame: Throughout study period, up to 6 months]
Delirium in patients treated with steroids [Time Frame: Throughout study period, up to 6 months]
Delirium in patients treated with hypnotics [Time Frame: Throughout study period, up to 6 months]
Delirium related to number of ventilator days [Time Frame: Throughout study period, up to 6 months]
Delirium related to sedation [Time Frame: Throughout study period, up to 6 months]
Distribution of types of delirium [Time Frame: Throughout study period, up to 6 months]
Delirium related to admission type [Time Frame: Throughout study period, up to 6 months]
Secondary ID(s)
SE-DELIR1-15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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