Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors

Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07373561

Acronym

PICAS-DK

Enrollment

800

Registered

2026-01-28

Start date

2026-06-01

Completion date

2028-09-30

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit (ICU) Patients, Post-Intensive Care Syndrome (PICS), Symptom Burden

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Presence of PICS at 12 months after ICU admission	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

Measure	Time frame	Description
Prevalence of PICS at 3 and 6 months	Data will be collected at 3 and 6 months post-discharge	The proportion of participants meeting the PICS definition at 3 and 6 months post-discharge, using the same domain criteria as for the 12-month primary outcome.

Outcome results