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

NCT07373561 | Not Yet Recruiting

• 1 other identifier: ID not known yet
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Presence of PICS at 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.

  12 months after ICU admission

Secondary Outcomes (1)

• Prevalence of PICS at 3 and 6 months

  Data will be collected at 3 and 6 months post-discharge

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Danish ICU-patients admitted to an intensive care unit at any of the participating hospitals in Denmark.

You may qualify if:

• Adult patients ≥ 18 years of age
• Admitted to the intensive care unit for ≥48 hours
• Acutely admitted to the intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

MeSH Terms

Conditions

postintensive care syndrome

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Ph.D, Critical Care Registered Nurse

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01