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Not yet recruiting NCT07373561

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post-Intensive Care Syndrome (PICS), Symptom Burden, Intensive Care Unit (ICU) Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Presence of PICS at 12 months after ICU admission [Time frame: 12 months after ICU admission]
Secondary outcome measures (1)
  • Prevalence of PICS at 3 and 6 months [Time frame: Data will be collected at 3 and 6 months post-discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373561 · ID not known yet

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗