Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Zealand University Hospital
- Enrollment
- 800
- Primary Endpoint
- Presence of PICS at 12 months after ICU admission
Study Overview
Brief Summary
The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time.
Research question
- What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission?
- How do the components of PICS evolve during the follow-up period (trajectory)?
- What risk factors are associated with the development of PICS in ICU survivors?
- Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)?
The hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients ≥ 18 years of age
- •Admitted to the intensive care unit for ≥48 hours
- •Acutely admitted to the intensive care unit
Exclusion Criteria
- •Patients with limited treatment
- •Foreign patients
- •Pregnant women
- •Patient with impaired cognitive function (e.g. dementia, intellectual disability)
- •Patient without Danish citizenship
- •Patient with limited proficiency in the Danish language
Arms & Interventions
ICU patients
This study investigates ICU survivor patients in Denmark and aim to estimate the prevalence of post-intensive care syndrome within this group. There are three different follow-up times.
Outcomes
Primary Outcomes
Presence of PICS at 12 months after ICU admission
Time Frame: 12 months after ICU admission
Presence of PICS at 12 months after ICU admission, defined as impairment in at least one of the three domains (physical, cognitive or mental health) measured with validated instruments and pre-specified cut-off values.
Secondary Outcomes
- Prevalence of PICS at 3 and 6 months(Data will be collected at 3 and 6 months post-discharge)
Investigators
Camilla Bekker Mortensen
Assistant Professor, Ph.D, Critical Care Registered Nurse
Zealand University Hospital