Post-Intensive Care Syndrome (PICS)PICAS-DKNCT07373561
Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors
An observational study of Post-Intensive Care Syndrome (PICS) and Symptom Burden, run by Zealand University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome (PICS), Symptom Burden, Intensive Care Unit (ICU) Patients
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Sep 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish ICU-patients admitted to an intensive care unit at any of the participating hospitals in Denmark.
Who may be able to join
- Adult patients ≥ 18 years of age
- Admitted to the intensive care unit for ≥48 hours
- Acutely admitted to the intensive care unit
Who cannot join
- 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
About this study
Official title: Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)
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
Read more
- 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.
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Data will be collected at 3 and 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Bekker Mortensen, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373561
- Sponsor's protocol ID
- ID not known yet
- Acronym
- PICAS-DK
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)
- ClinicalTrials.gov ID
- NCT07373561
- Acronym / sponsor ID
- PICAS-DK / ID not known yet
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish ICU-patients admitted to an intensive care unit at any of the participating hospitals in Denmark.
Key inclusion criteria (3 listed)
- Adult patients ≥ 18 years of age
- Admitted to the intensive care unit for ≥48 hours
- Acutely admitted to the intensive care unit
Key exclusion criteria (6 listed)
- Patients with limited treatment
- Foreign patients
- Pregnant women
- Patient with impaired cognitive function (e.g. dementia, intellectual disability)
- Patient without Danish citizenship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prevalence of PICS at 3 and 6 months
Time frame: Data will be collected at 3 and 6 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Intensive Care Syndrome (PICS) and Symptom Burden, run by Zealand University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of PICS at 12 months after ICU admission (time frame: 12 months after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.