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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZealand University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients ≥ 18 years of age

Admitted to the intensive care unit for ≥48 hours

Acutely admitted to the intensive care unit

Disqualifiers

Patients with limited treatment

Foreign patients

Pregnant women

Patient with impaired cognitive function (e.g. dementia, intellectual disability)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 1 trial group
Group A: ICU patients

Trial outcomes

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.

Time frame
12 months after ICU admission

Secondary outcomes

1

Prevalence of PICS at 3 and 6 months

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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