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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02599428
Date of registration:	04/11/2015
Prospective Registration:	Yes
Primary sponsor:	Zealand University Hospital
Public title:	Recovery After ICU Treatment: A Prospective Cohort Study
Scientific title:	Recovery After ICU Treatment: A Prospective Cohort Study
Date of first enrolment:	February 2016
Target sample size:	161
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02599428
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Denmark

Contacts

Name:	Ole Mathiesen, MD
Address:
Telephone:
Email:
Affiliation:	Zealand University Hospital, Køge Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients > 18 years of age

- Admitted to the ICU for > 24 h

Exclusion Criteria:

- Not able to speak and understand Danish

- Discharged from the ICU to terminal care

- Patients transferred to another hospital during ICU stay

- Patients living outside the Region of Zealand

- Patient with severe dementia

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Quality of Life

Critical Illness

Delirium

Intervention(s)

Primary Outcome(s)

Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) [Time Frame: 3 months after discharge]

Secondary Outcome(s)

Consumption of opioids at admission and on follow up [Time Frame: At admission to hospital, at 3 month follow up]

Mortality [Time Frame: At discharge from hospital (variable time) and at 90 days postdischarge]

Receiving statins before and after ICU stay [Time Frame: At admission to hospital, at 3 month follow up]

Consumption of anti-depressants before and after ICU stay [Time Frame: At admission to hospital, at 3 month follow up]

Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) [Time Frame: 12 months after discharge]

Adherence to checklist based on rehabilitation guidelines [Time Frame: At discharge from hospital and 3 months]

Anxiety and depression measured by Hospital anxiety and depression scale (HADS) [Time Frame: 3 and 12 months]

Physical function measured by Chelsea critical care physical assessment tool (CPAx) [Time Frame: 3 and 12 months]

Delirium at the ICU measured by CAM-ICU [Time Frame: At discharge from ICU (variable time)]

Health related quality of life measured by Short form health survey (SF 36) [Time Frame: 3 and 12 months]

Secondary ID(s)

SE 1-16

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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