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NCT Number: NCT07373561

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

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.

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Key information

Conditions

Post-Intensive Care Syndrome (PICS) Intensive Care Unit (ICU) Patients Symptom Burden postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Prevalence of PICS at 3 and 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: PICAS-DK

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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