Post-Intensive Care Syndrome (PICS)NCT06671795
ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)
An observational study of Post-Intensive Care Syndrome (PICS), run by Medical University of Vienna at 1 site in Austria.
Trial summary
The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Intensive Care Syndrome (PICS)
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jan 2024to 30 Sep 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 65 who have been admitted to the Intensive Care Unit (ICU) at the Department of Anesthesia, Intensive Care Medicine, and Pain Medicine at the Medical University of Vienna. Participants are selected based on an ICU stay of at least 48 hours and must provide written informed consent. Patients transferred from other ICUs, those with legal guardians, individuals experiencing homelessness, or those residing outside of Austria are excluded.
Who may be able to join
- ICU stay of at least 48 hours
- Age between 18 and 65 years at the time of ICU admission
- Written informed consent
Who cannot join
- Transfer from another ICU outside of the Medical University of Vienna
- Patient with a legal guardian
- Homelessness
- Place of residence outside of Austria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Akos Tiboldi, Dr.med.univ., +4314040041000, akos.tiboldi@meduniwien.ac.at
Oliver Kimberger, Univ. Prof. Dr., +4314040041000, oliver.kimberger@meduniwien.ac.at
About this study
Official title: Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome
The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours.
The main questions it aims to answer are:
Read more
What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function?
Participants will:
Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge.
Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function.
Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress.
This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.
- Conditions
- Post-Intensive Care Syndrome (PICS)
- Keywords
- Post-Intensive Care Syndrome (PICS), ICU Biobank, Long-term ICU outcomes, Cognitive impairment, Physical impairment, Psychological impairment, Health-related quality of life (HRQoL), Epigenetics in critical care, ICU recovery clinic
- Medical subject headings
- postintensive care syndrome, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PICS and its components
Incidence of Post-Intensive Care Syndrome (PICS), defined as new or worsened impairments in physical, cognitive, or mental function persisting beyond hospital stay. Patients scoring above/below predefined cut-offs on any of the assessments (detailed below) will be diagnosed with PICS.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Health-related quality of life (HRQoL) using EQ-5D-5L
- The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Health-Related Quality of Life (HRQoL) using SF-36
HRQoL assessed with SF-36, covering eight health domains. Results will be aggregated into two composite scores: Physical Component Summary (PCS) and Mental Component Summary (MCS), with higher scores indicating a more favorable health state.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive Function using Montreal Cognitive Assessment (MoCA)
Cognitive function measured by the MoCA, with scores below 24 indicating impairment. Only patients with prior normal cognitive function are eligible.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Cognitive decline assessed with IQCODE, a validated informant questionnaire. Scores range from 1 (much improved) to 5 (much worse), with a cutoff average score of ≥3.31 indicating cognitive decline.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Anxiety and Depression Symptoms using HADS
Anxiety and depression symptoms measured with HADS. Subscale scores ≥8 indicate significant anxiety or depression.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R)
PTSD symptoms measured with the IES-R. Scores range from 0 (not at all) to 4 (extremely), with an average score of ≥1.6 indicating clinically significant PTSD symptoms.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical Function using 6-Minute Walk Test (6MWT)
Deterioration in the 6-Minute Walking Test (6-MWT) defined as a change in the target value of the walking distance calculated using the following equation:
218 + (5,14 x height - 5,32 x age) - 1,8 x weight + 51,31 x gender (height in cm, age in years, weight in kg, female 0 / male 1)
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx)
Physical function measured by CPAx, assessing various functional activities (grip strength, respiratory function, moving, sitting, standing, transferring, and stepping). Each domain is scored from 0 to 5, with an overall score from 0 (dependent) to 50 (fully independent).
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary Function - FEV1/FVC Ratio
Pulmonary function assessed by FEV1/FVC ratio (Tiffeneau index); a value below the 5th percentile indicates obstructive ventilation disorder.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary Function using Total Lung Capacity (TLC)
Pulmonary function assessed by total lung capacity (TLC), where values below the 5th percentile indicate a restrictive ventilation disorder.
Measured: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Secondary outcomes (2)
Pain and Discomfort using EQ-5D-5L
The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category
Measured: 4-5 weeks, 6 months and 10-12 months after ICU discharge
Frailty Status using Clinical Frailty Scale
Frailty measured by the Clinical Frailty Scale, with scores ranging from 1 (very fit) to 9 (terminally ill). Scores of 1-4 are classified as non-frail; 5-9 as frail.
Measured: 4-5 weeks, 6 months and 10-12 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start28 Jan 2024
- Primary completionJul 2026 (estimated)
- Study completion30 Sep 2026 (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 Medical University of ViennaThe 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
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akos Tiboldi, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671795
- Sponsor's protocol ID
- SASICUPICS2012/2023
- Other IDs
- 101132808
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study plans to share de-identified individual participant data (IPD) with other researchers to facilitate additional research on Post-Intensive Care Syndrome (PICS). Shared data will include information related to health outcomes, quality of life assessments, and biomarker findings. Access will be granted through a controlled database managed by the Medical University of Vienna, upon reasonable request and approval by the study's ethics board.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome
- ClinicalTrials.gov ID
- NCT06671795
- Acronym / sponsor ID
- SASICUPICS2012/2023
- Conditions
- Post-Intensive Care Syndrome (PICS)
- Keywords
- Post-Intensive Care Syndrome (PICS), ICU Biobank, Long-term ICU outcomes, Cognitive impairment, Physical impairment, Psychological impairment, Health-related quality of life (HRQoL), Epigenetics in critical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Nov 2024 (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 goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours.
The main questions it aims to answer are:
What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function?
Participants will:
Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge.
Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function.
Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress.
This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 65 who have been admitted to the Intensive Care Unit (ICU) at the Department of Anesthesia, Intensive Care Medicine, and Pain Medicine at the Medical University of Vienna. Participants are selected based on an ICU stay of at least 48 hours and must provide written informed consent. Patients transferred from other ICUs, those with legal guardians, individuals experiencing homelessness, or those residing outside of Austria are excluded.
Key inclusion criteria (3 listed)
- ICU stay of at least 48 hours
- Age between 18 and 65 years at the time of ICU admission
- Written informed consent
Key exclusion criteria (4 listed)
- Transfer from another ICU outside of the Medical University of Vienna
- Patient with a legal guardian
- Homelessness
- Place of residence outside of Austria
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
Incidence of PICS and its components
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Incidence of Post-Intensive Care Syndrome (PICS), defined as new or worsened impairments in physical, cognitive, or mental function persisting beyond hospital stay. Patients scoring above/below predefined cut-offs on any of the assessments (detailed below) will be diagnosed with PICS.
Health-related quality of life (HRQoL) using EQ-5D-5L
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
a. The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category.
Health-Related Quality of Life (HRQoL) using SF-36
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
HRQoL assessed with SF-36, covering eight health domains. Results will be aggregated into two composite scores: Physical Component Summary (PCS) and Mental Component Summary (MCS), with higher scores indicating a more favorable health state.
Cognitive Function using Montreal Cognitive Assessment (MoCA)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive function measured by the MoCA, with scores below 24 indicating impairment. Only patients with prior normal cognitive function are eligible.
Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive decline assessed with IQCODE, a validated informant questionnaire. Scores range from 1 (much improved) to 5 (much worse), with a cutoff average score of ≥3.31 indicating cognitive decline.
Anxiety and Depression Symptoms using HADS
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Anxiety and depression symptoms measured with HADS. Subscale scores ≥8 indicate significant anxiety or depression.
Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
PTSD symptoms measured with the IES-R. Scores range from 0 (not at all) to 4 (extremely), with an average score of ≥1.6 indicating clinically significant PTSD symptoms.
Physical Function using 6-Minute Walk Test (6MWT)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Deterioration in the 6-Minute Walking Test (6-MWT) defined as a change in the target value of the walking distance calculated using the following equation: 218 + (5,14 x height - 5,32 x age) - 1,8 x weight + 51,31 x gender (height in cm, age in years, weight in kg, female 0 / male 1)
Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical function measured by CPAx, assessing various functional activities (grip strength, respiratory function, moving, sitting, standing, transferring, and stepping). Each domain is scored from 0 to 5, with an overall score from 0 (dependent) to 50 (fully independent).
Pulmonary Function - FEV1/FVC Ratio
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary function assessed by FEV1/FVC ratio (Tiffeneau index); a value below the 5th percentile indicates obstructive ventilation disorder.
Pulmonary Function using Total Lung Capacity (TLC)
Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary function assessed by total lung capacity (TLC), where values below the 5th percentile indicate a restrictive ventilation disorder.
2 secondary outcomes
Pain and Discomfort using EQ-5D-5L
Time frame: 4-5 weeks, 6 months and 10-12 months after ICU discharge
Frailty Status using Clinical Frailty Scale
Time frame: 4-5 weeks, 6 months and 10-12 months after ICU 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 4 Nov 2024.
- Individual participant dataSharing planned: Yes. The study plans to share de-identified individual participant data (IPD) with other researchers to facilitate additional research on Post-Intensive Care Syndrome (PICS). Shared data will include information related to health outcomes, quality of life assessments, and biomarker findings. Access will be granted through a controlled database managed by the Medical University of Vienna, upon reasonable request and approval by the study's ethics board.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Intensive Care Syndrome (PICS), run by Medical University of Vienna at 1 site in Austria.
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 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Akos Tiboldi, Dr.med.univ. (+4314040041000, akos.tiboldi@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PICS and its components (time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge). The study lists 11 primary outcomes in all. 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 4 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.