PICSPICS-DACHNCT07290712
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
An observational study of PICS and PICS-F, run by Medical University of Vienna at 4 sites in 2 countries.
Trial summary
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 5,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Feb 2026to 1 Nov 2035
- How long will I take part?
- 5 Years
- 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: Intensive care unit patients
Who may be able to join
- Patients with an ICU stay longer than 72 hours will be included
Who cannot join
- Age < 18 years old
- Patients who receive end-of-life care at the time of screening
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Study Coordination AAI MUV contact
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
Philipp Simon, MD, philipp.simon3@uk-augsburg.de
Manfred Weiss, MD, manfred.weiss@uk-augsburg.de
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Claudia Spies, MD, +49 30 450 531 012, claudia.spies@charite.de
Claudia Denke, Dr., claudia. denke@ charite. de
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Patrick Meybohm, MD, meybohm_p@ukw.de
Christian Stoppe, MD, stoppe_c@ukw.de
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Stefan J Schaller, MD, +4314040041020, aai-research@meduniwien.ac.at
Marion Wiegele, MD
About this study
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective registry study aims to identify risk factors and long-term consequences of PICS and PICS-F.
The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.
Read the detailed description
BACKGROUND Post-Intensive Care Syndrome (PICS) refers to newly occurring or intensified cognitive, physical, and psychological long-term effects, as well as pain and socioeconomic effects resulting from intensive care treatment. Symptoms can appear as early as 24 hours after admission to the intensive care unit (ICU) and persist for 5-15 years after discharge. The rate of affected individuals is very high. Three months after discharge due to an illness requiring intensive care, 64% of survivors were impaired in at least one of the three functional areas, and 56% were impaired after 12 months. The hospitalization of a close relative in the ICU affects the entire family system, i.e., all people with whom the patients have a significant relationship. The effects on the family or relatives are referred to as Post-Intensive Care Syndrome-Family (PICS-F), which represents a significant burden for up to 94% of relatives. PICS and PICS-F are therefore of high socioeconomic importance.
RELEVANCE Given the significant impact of PICS on patients, their families, and the socioeconomic system, gaining insights into the prevalence of risk factors and PICS criteria during ICU stay, as well as PICS and PICS-F after ICU discharge and hospital release, is highly valuable.
DESIGN
The study is divided into the following six modules:
- ICU module
- Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
- Environment module
- Psychiatry module
- Translational module
- Family system module (PICS-F) The participating centers take part in at least the first module, the ICU module, in which the risk factors and PICS as well as PICS-F domains are recorded during the intensive care stay. Depending on local conditions, capacity, and resources, the participating centers optionally participate in modules 2 to 6. In the individual modules, there is also the option of participating in a mode available to all centers or specialized for individual centers (e.g., functional tests that can only be performed in a PICS outpatient clinic (PICA)). For centers without PICA, follow-up observation is carried out, for example, via questionnaires. The corresponding mode of participation with and without PICA is displayed accordingly in the individual modules.
PRIMARY OBJECTIVE
- The primary objective of the prospective registry is to record and investigate the risk factors, diagnostic and therapeutic options for PICS and PICS-F.
SECONDARY OBJECTIVES
- Recording the frequency of multiple risk factors for and the manifestation of PICS and PICS-F during and after treatment in an intensive care unit.
- Recording the rate of risk factors, especially the modifiable risk factors of PICS in different disease entities, such as sepsis, delirium, and other underlying diseases requiring intensive care.
- Determination of cut-off values and rates of significant cognitive, physical and psychological impairments as well as pain.
- Assessment of the significance for PICS between and within individual dimensions of PICS.
- Estimation of incidence based on risk factors or different cut-off values for scores to define significant limitations at the cognitive, physical and psychological levels as well as chronic pain.
- Determination and investigation of the influence of relevant external and internal environmental factors that contribute to the development and course of PICS/PICS-F.
- Identification of molecular biological or pathophysiological processes of PICS.
PROCEDURE
- Examination using standardized questionnaires during intensive care. The aim is to record cognitive, physical, and psychological functional impairments as well as pain (= PICS and PICS-F rates) while still in the intensive care unit. The patient and their relatives and friends are interviewed.
- Follow-up examination using standardized questionnaires in the PICS outpatient clinic 1-3 and 6 months after discharge from the intensive care unit. The aim of these appointments is to record cognitive, physical, and psychological functional impairments as well as pain.
- Completion of standardized questionnaires to record cognitive, physical, and psychological functional impairments as well as pain (1, 2, and 5 years after discharge from the intensive care unit; this can be done by telephone, electronically, by mail, via telemedicine, or in PICA).
- Blood samples for the creation of a biobank (depending on follow-up appointments at the PICS study outpatient clinic: 4-7x 27ml each; timing: during ICU (inclusion (> 72h ICU stay) and ICU discharge), 1-3 months, 6 months and, if applicable, 1, 2, and 5 years after ICU discharge.
- Keywords
- PICS, PICS-F, ICU, Intensive Care Unit, Critical Care, Critical Illness, Post Intensive Care Syndrome, Post Intensive Care Syndrome Family
- Medical subject headings
- Critical Illness, postintensive care syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Post-Intensive Care Syndrome (PICS)
Frequency of PICS diagnosis defined as the presence of at least one new or worsened impairment in one of the PICS domains (number/percentage)
Measured: up to 5 years
Secondary outcomes (34)
Frequency of PICS sub-domains
Frequency of diagnosis of PICS-subdomains
Measured: up to 5 years
Frailty status
Frailty status assessed by the Clinical Frailty Scale (CFS; score 1-9, higher scores indicate worse frailty).
Measured: up to 5 years
Post-Intensive Care Syndrome symptoms assessed by the PICS Questionnaire (PICSq)
PICS symptoms assessed by the PICSq (validated questionnaire 0-45 points; higher scores indicate greater impairment).
Measured: up to 5 years
Physical function assessed by the Barthel Index
Change in activities of daily living, assessed by the Barthel Index (score 0-100; higher scores indicate better function).
Measured: up to 5 years
Physical function assessed by the Timed Up-and-Go Test
Change in mobility, assessed by the Timed Up-and-Go(time in seconds; longer times indicate worse performance).
Measured: up to 5 years
Physical function assessed by Handgrip Strength
Muscle strength, assessed by handgrip dynamometry (maximum grip strength in kg; higher values indicate better function).
Measured: up to 5 years
Physical function assessed by the 6-Minute Walk Test (6MWT)
6MWT (distance walked in meters; higher values indicate better function).
Measured: up to 5 years
Physical function assessed by the 2-Minute Walk Test (2MWT)
´2MWT (distance walked in meters; higher values indicate better function).
Measured: up to 5 years
Physical function assessed by the SPPB
Physical function, assessed by the Short Physical Performance Battery (SPPB, score 0-12; higher scores indicate better performance).
Measured: up to 5 years
Nutritional status assessed by the MNA
Nutritional status, assessed by the Mini Nutritional Assessment (MNA, score 0-30; higher scores indicate better nutritional status).
Measured: up to 5 years
Health-related quality of life assessed by EQ-5D-5L
Health-related quality of life, assessed by the EQ-5D-5L (index score; higher values indicate better quality of life).
Measured: up to 5 years
Disability assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)
Disability, assessed by the WHODAS 2.0, with higher scores indicating greater disability.
Measured: up to 5 years
Cognitive function assessed by the MiniCog
Cognitive function, assessed by the MiniCog (score 0-5; higher scores indicate better cognition).
Measured: up to 5 years
Cognitive function assessed by the Animal Naming Test
Verbal fluency, assessed by the Animal Naming Test (number of animals named in 60 seconds; higher values indicate better cognition).
Measured: up to 5 years
Cognitive function assessed by the RBANS
Cognition, assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; higher scores indicate better cognition).
Measured: up to 5 years
Cognitive function assessed by the TMT
Executive function, assessed by the Trail Making Test (TMT A and B, completion time in seconds; longer times indicate worse performance).
Measured: up to 5 years
Depression assessed by the PHQ
Depression severity, assessed by the Patient Health Questionnaire (PHQ, higher scores indicate worse depression).
Measured: up to 5 years
Anxiety assessed by the GAD
Anxiety severity, assessed by the Generalized Anxiety Disorder scale (GAD, higher scores indicate worse anxiety).
Measured: up to 5 years
PTSD symptoms assessed by the IES-R
Post-traumatic stress disorder (PTSD) symptoms, assessed by the Impact of Event Scale - Revised (IES-R; higher scores indicate worse PTSD symptoms).
Measured: up to 5 years
Pain assessed by the McGill Pain Questionnaire
Pain severity, assessed by the McGill Pain Questionnaire (higher scores indicate worse pain).
Measured: up to 5 years
Frequency of dysphagia
Frequency of clinically diagnosed swallowing disorder (number / percentage)
Measured: up to 5 years
Work ability and disability days
Change in employment status and number of disability days from baseline to 5 years, assessed by self-report (more disability days indicate worse outcome).
Measured: 5 years
Psychiatric or psychotherapeutic care utilization
Use of psychiatric or psychotherapeutic services (yes/no), assessed from baseline to 5 years.
Measured: 5 years
Noise annoyance assessed by the 11-point numeric noise-annoyance scale
Change in noise annoyance from baseline to 5 years, assessed by the 11-point numeric scale (0-10; higher scores indicate higher annoyance).
Measured: 5 years
Noise annoyance assessed by the 5-point verbal scale
Change in noise annoyance from baseline to 5 years, assessed by the 5-point verbal scale (1-5; higher scores indicate higher annoyance).
Measured: 5 years
Noise sensitivity assessed by the LEF-K questionnaire
Change in noise sensitivity from baseline to 5 years, assessed by the LEF-K (higher scores indicate greater sensitivity).
Measured: 5 years
ICU environmental exposure measured by HIAwear/Sensorbox
Change in ICU environmental exposure from baseline to 5 years, measured continuously with HIAwear/Sensorbox (parameters include noise, light, particulate matter, temperature, humidity; higher values indicate greater exposure).
Measured: 5 years
Atmospheric environmental exposure (ozone, nitrogen oxides, carbon monoxide, particulate matter)
Change in atmospheric exposure from baseline to 5 years, assessed by pollutant concentrations (O3, NO, NO2, NOx, CO, PM1, PM2.5, PM10; higher values indicate greater exposure).
Measured: 5 years
Anxiety and depression in relatives assessed by the HADS
Change in anxiety and depression symptoms of relatives from baseline to 5 years, assessed by the HADS (score 0-21; higher scores indicate worse symptoms).
Measured: 5 years
Post-traumatic stress in relatives assessed by the IES-R
Change in PTSD symptoms of relatives from baseline to 5 years, assessed by the IES-R (higher scores indicate worse PTSD symptoms).
Measured: 5 years
Work ability of relatives
Change in work status and disability days of relatives from baseline to 5 years, assessed by self-report (more disability days indicate worse outcome).
Measured: 5 years
Psychiatric or psychotherapeutic care utilization by relatives
Use of psychiatric or psychotherapeutic services (yes/no), assessed in relatives from baseline to 5 years.
Measured: 5 years
Body resistance (R)
Body resistance (R) measured by BIA (Body impedance analysis)
Measured: up to 5 years
Body reactance (Xc)
Body reactance (Xc) measured by BIA (Body impedance analysis)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start4 Feb 2026
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PICSStudies 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Wuerzburg, University Hospital Augsburg
- Responsible party
- Principal investigator, Stefan Schaller, Medical University of Vienna
- Investigators
- Stefan J Schaller, MD, Principal investigator, Medical University of VieannaBjoern Weiss, MD, Principal investigator, Charite University, Berlin, GermanyClaudia Denke, Dr., Principal investigator, Charite University, Berlin, GermanyPatrick Meybohm, MD, Principal investigator, Wuerzburg University HospitalPhilipp Simon, MD, Principal investigator, Universitätsklinikum AugsburgClaudia Spies, MD, Principal investigator, Charite University, Berlin, GermanyChristian Stoppe, MD, Principal investigator, Wuerzburg University HospitalManfred Weiss, MD, Principal investigator, Universitätsklinikum Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290712
- Sponsor's protocol ID
- PICS-DACH
- Acronym
- PICS-DACH
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Jeong YJ, Kang J. Development and validation of a questionnaire to measure post-intensive care syndrome. Intensive Crit Care Nurs. 2019 Dec;55:102756. doi: 10.1016/j.iccn.2019.102756. Epub 2019 Sep 12.
PubMed 31522829Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
- ClinicalTrials.gov ID
- NCT07290712
- Acronym / sponsor ID
- PICS-DACH / PICS-DACH
- Keywords
- PICS, PICS-F, ICU, Intensive Care Unit, Critical Care, Critical Illness, Post Intensive Care Syndrome, Post Intensive Care Syndrome Family
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Wuerzburg, University Hospital Augsburg
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2035 (estimated)
- First posted
- 18 Dec 2025 (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.
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective registry study aims to identify risk factors and long-term consequences of PICS and PICS-F.
The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.
Detailed description
BACKGROUND Post-Intensive Care Syndrome (PICS) refers to newly occurring or intensified cognitive, physical, and psychological long-term effects, as well as pain and socioeconomic effects resulting from intensive care treatment. Symptoms can appear as early as 24 hours after admission to the intensive care unit (ICU) and persist for 5-15 years after discharge. The rate of affected individuals is very high. Three months after discharge due to an illness requiring intensive care, 64% of survivors were impaired in at least one of the three functional areas, and 56% were impaired after 12 months. The hospitalization of a close relative in the ICU affects the entire family system, i.e., all people with whom the patients have a significant relationship. The effects on the family or relatives are referred to as Post-Intensive Care Syndrome-Family (PICS-F), which represents a significant burden for up to 94% of relatives. PICS and PICS-F are therefore of high socioeconomic importance.
RELEVANCE Given the significant impact of PICS on patients, their families, and the socioeconomic system, gaining insights into the prevalence of risk factors and PICS criteria during ICU stay, as well as PICS and PICS-F after ICU discharge and hospital release, is highly valuable.
DESIGN
The study is divided into the following six modules:
- ICU module
- Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
- Environment module
- Psychiatry module
- Translational module
- Family system module (PICS-F) The participating centers take part in at least the first module, the ICU module, in which the risk factors and PICS as well as PICS-F domains are recorded during the intensive care stay. Depending on local conditions, capacity, and resources, the participating centers optionally participate in modules 2 to 6. In the individual modules, there is also the option of participating in a mode available to all centers or specialized for individual centers (e.g., functional tests that can only be performed in a PICS outpatient clinic (PICA)). For centers without PICA, follow-up observation is carried out, for example, via questionnaires. The corresponding mode of participation with and without PICA is displayed accordingly in the individual modules.
PRIMARY OBJECTIVE
- The primary objective of the prospective registry is to record and investigate the risk factors, diagnostic and therapeutic options for PICS and PICS-F.
SECONDARY OBJECTIVES
- Recording the frequency of multiple risk factors for and the manifestation of PICS and PICS-F during and after treatment in an intensive care unit.
- Recording the rate of risk factors, especially the modifiable risk factors of PICS in different disease entities, such as sepsis, delirium, and other underlying diseases requiring intensive care.
- Determination of cut-off values and rates of significant cognitive, physical and psychological impairments as well as pain.
- Assessment of the significance for PICS between and within individual dimensions of PICS.
- Estimation of incidence based on risk factors or different cut-off values for scores to define significant limitations at the cognitive, physical and psychological levels as well as chronic pain.
- Determination and investigation of the influence of relevant external and internal environmental factors that contribute to the development and course of PICS/PICS-F.
- Identification of molecular biological or pathophysiological processes of PICS.
PROCEDURE
- Examination using standardized questionnaires during intensive care. The aim is to record cognitive, physical, and psychological functional impairments as well as pain (= PICS and PICS-F rates) while still in the intensive care unit. The patient and their relatives and friends are interviewed.
- Follow-up examination using standardized questionnaires in the PICS outpatient clinic 1-3 and 6 months after discharge from the intensive care unit. The aim of these appointments is to record cognitive, physical, and psychological functional impairments as well as pain.
- Completion of standardized questionnaires to record cognitive, physical, and psychological functional impairments as well as pain (1, 2, and 5 years after discharge from the intensive care unit; this can be done by telephone, electronically, by mail, via telemedicine, or in PICA).
- Blood samples for the creation of a biobank (depending on follow-up appointments at the PICS study outpatient clinic: 4-7x 27ml each; timing: during ICU (inclusion (> 72h ICU stay) and ICU discharge), 1-3 months, 6 months and, if applicable, 1, 2, and 5 years after ICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients
Key inclusion criteria (1 listed)
- Patients with an ICU stay longer than 72 hours will be included
Key exclusion criteria (2 listed)
- Age < 18 years old
- Patients who receive end-of-life care at the time of screening
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
Diagnosis of Post-Intensive Care Syndrome (PICS)
Time frame: up to 5 years
Frequency of PICS diagnosis defined as the presence of at least one new or worsened impairment in one of the PICS domains (number/percentage)
34 secondary outcomes
Frequency of PICS sub-domains
Time frame: up to 5 years
Frailty status
Time frame: up to 5 years
Post-Intensive Care Syndrome symptoms assessed by the PICS Questionnaire (PICSq)
Time frame: up to 5 years
Physical function assessed by the Barthel Index
Time frame: up to 5 years
Physical function assessed by the Timed Up-and-Go Test
Time frame: up to 5 years
Physical function assessed by Handgrip Strength
Time frame: up to 5 years
Physical function assessed by the 6-Minute Walk Test (6MWT)
Time frame: up to 5 years
Physical function assessed by the 2-Minute Walk Test (2MWT)
Time frame: up to 5 years
Physical function assessed by the SPPB
Time frame: up to 5 years
Nutritional status assessed by the MNA
Time frame: up to 5 years
Health-related quality of life assessed by EQ-5D-5L
Time frame: up to 5 years
Disability assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: up to 5 years
Cognitive function assessed by the MiniCog
Time frame: up to 5 years
Cognitive function assessed by the Animal Naming Test
Time frame: up to 5 years
Cognitive function assessed by the RBANS
Time frame: up to 5 years
Cognitive function assessed by the TMT
Time frame: up to 5 years
Depression assessed by the PHQ
Time frame: up to 5 years
Anxiety assessed by the GAD
Time frame: up to 5 years
PTSD symptoms assessed by the IES-R
Time frame: up to 5 years
Pain assessed by the McGill Pain Questionnaire
Time frame: up to 5 years
Frequency of dysphagia
Time frame: up to 5 years
Work ability and disability days
Time frame: 5 years
Psychiatric or psychotherapeutic care utilization
Time frame: 5 years
Noise annoyance assessed by the 11-point numeric noise-annoyance scale
Time frame: 5 years
Noise annoyance assessed by the 5-point verbal scale
Time frame: 5 years
Noise sensitivity assessed by the LEF-K questionnaire
Time frame: 5 years
ICU environmental exposure measured by HIAwear/Sensorbox
Time frame: 5 years
Atmospheric environmental exposure (ozone, nitrogen oxides, carbon monoxide, particulate matter)
Time frame: 5 years
Anxiety and depression in relatives assessed by the HADS
Time frame: 5 years
Post-traumatic stress in relatives assessed by the IES-R
Time frame: 5 years
Work ability of relatives
Time frame: 5 years
Psychiatric or psychotherapeutic care utilization by relatives
Time frame: 5 years
Body resistance (R)
Time frame: up to 5 years
Body reactance (Xc)
Time frame: up to 5 years
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 25 Aug 2026.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 31522829Jeong YJ, Kang J. Development and validation of a questionnaire to measure post-intensive care syndrome. Intensive Crit Care Nurs. 2019 Dec;55:102756. doi: 10.1016/j.iccn.2019.102756. Epub 2019 Sep 12.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Webpage of the PICS-DACH ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Study Coordination AAI MUV contact
Stefan J Schaller, MD principal investigator
Medical University of Vieanna
Bjoern Weiss, MD principal investigator
Charite University, Berlin, Germany
Claudia Denke, Dr. principal investigator
Charite University, Berlin, Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PICS and PICS-F, run by Medical University of Vienna at 4 sites in 2 countries.
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 1 inclusion and 2 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, 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 PICS-DACH Steering Committee (+4314040041020, pics-dach-sc@listserv.muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Post-Intensive Care Syndrome (PICS) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07290712, which also lists 3 linked publications.
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 25 Aug 2026.