Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region (PICS-DACH)

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.

Study Overview

• Status: Recruiting
• Conditions: PICS; PICS-F

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:

1. ICU module
2. Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
3. Environment module
4. Psychiatry module
5. Translational module
6. 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

1. 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.
2. 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.
3. 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).
4. 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: PICS-DACH Steering Committee; Phone Number: +4314040041020; Email: pics-dach-sc@listserv.muv.ac.at
• Study Contact Backup: Name: Study Coordination AAI MUV; Email: aai-research@muv.ac.at

Study Locations

• Austria
  • Vienna
    • Vienna, Vienna, Austria, 1090
      • Recruiting
      • Medical University of Vienna
      • Contact: Stefan J Schaller, MD; Phone Number: +4314040041020; Email: aai-research@meduniwien.ac.at
      • Contact: Marion Wiegele, MD
• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Not yet recruiting
      • Universitätsklinikum Augsburg
      • Contact: Philipp Simon, MD; Email: philipp.simon3@uk-augsburg.de
      • Contact: Manfred Weiss, MD; Email: manfred.weiss@uk-augsburg.de
    • Würzburg, Bavaria, Germany, 97080
      • Not yet recruiting
      • Universitatsklinikum Wurzburg
      • Contact: Patrick Meybohm, MD; Email: meybohm_p@ukw.de
      • Contact: Christian Stoppe, MD; Email: stoppe_c@ukw.de
  • State of Berlin
    • Berlin, State of Berlin, Germany, 13353
      • Not yet recruiting
      • Charité - Universitätsmedizin Berlin
      • Contact: Claudia Spies, MD; Phone Number: +49 30 450 531 012; Email: claudia.spies@charite.de
      • Contact: Claudia Denke, Dr.; Email: claudia. denke@ charite. de
      • Principal Investigator: Bjoern Weiß, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intensive care unit patients

Description

Inclusion Criteria:

• Patients with an ICU stay longer than 72 hours will be included

Exclusion Criteria:

• Age < 18 years old
• Patients who receive end-of-life care at the time of screening

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of PICS sub-domains	Frequency of diagnosis of PICS-subdomains	up to 5 years
Frailty status	Frailty status assessed by the Clinical Frailty Scale (CFS; score 1-9, higher scores indicate worse frailty).	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).	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).	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).	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).	up to 5 years
Physical function assessed by the 6-Minute Walk Test (6MWT)	6MWT (distance walked in meters; higher values indicate better function).	up to 5 years
Physical function assessed by the 2-Minute Walk Test (2MWT)	´2MWT (distance walked in meters; higher values indicate better function).	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).	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).	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).	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.	up to 5 years
Cognitive function assessed by the MiniCog	Cognitive function, assessed by the MiniCog (score 0-5; higher scores indicate better cognition).	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).	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).	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).	up to 5 years
Depression assessed by the PHQ	Depression severity, assessed by the Patient Health Questionnaire (PHQ, higher scores indicate worse depression).	up to 5 years
Anxiety assessed by the GAD	Anxiety severity, assessed by the Generalized Anxiety Disorder scale (GAD, higher scores indicate worse anxiety).	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).	up to 5 years
Pain assessed by the McGill Pain Questionnaire	Pain severity, assessed by the McGill Pain Questionnaire (higher scores indicate worse pain).	up to 5 years
Frequency of dysphagia	Frequency of clinically diagnosed swallowing disorder (number / percentage)	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).	5 years
Psychiatric or psychotherapeutic care utilization	Use of psychiatric or psychotherapeutic services (yes/no), assessed from baseline to 5 years.	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).	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).	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).	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).	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).	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).	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).	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).	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.	5 years
Body resistance (R)	Body resistance (R) measured by BIA (Body impedance analysis)	up to 5 years
Body reactance (Xc)	Body reactance (Xc) measured by BIA (Body impedance analysis)	up to 5 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Charite University, Berlin, Germany; University of Wuerzburg; University Hospital Augsburg
• Investigators: Principal Investigator: Claudia Spies, MD, Charite University, Berlin, Germany; Principal Investigator: Patrick Meybohm, MD, Wuerzburg University Hospital; Principal Investigator: Stefan J Schaller, MD, Medical University of Vieanna; Principal Investigator: Bjoern Weiss, MD, Charite University, Berlin, Germany; Principal Investigator: Claudia Denke, Dr., Charite University, Berlin, Germany; Principal Investigator: Philipp Simon, MD, Universitätsklinikum Augsburg; Principal Investigator: Christian Stoppe, MD, Wuerzburg University Hospital; Principal Investigator: Manfred Weiss, MD, Universitätsklinikum Augsburg; Principal Investigator: Marion Wiegele, MD, Medical University of Vienna

Publications and helpful links

General 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.
• Rockwood 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.
• Jeong 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.

Helpful Links

• Webpage of the PICS-DACH Consortium

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2035

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ICU; Intensive Care Unit; Critical Illness; Critical Care; PICS; PICS-F; Post Intensive Care Syndrome; Post Intensive Care Syndrome Family
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; postintensive care syndrome
• Other Study ID Numbers: PICS-DACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The Study Protocol will be public. IPD can only be shared in a research collaboration with other researchers if data protection regulations allow it and after signing a data sharing and research collaboration contract. Start date after publication of the first PICS-DACH data.
• IPD Sharing Access Criteria: The Study Protocol will be public. IPD can only be shared in a research collaboration with other researchers if data protection regulations allow it and after signing a data sharing and research collaboration contract.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No