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

NCT07290712 | Recruiting

• 1 other identifier: PICS-DACH
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 4

Brief 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. 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.

Conditions

PICS; PICS-F

Keywords

PICS; PICS-F; ICU; Intensive Care Unit; Critical Care; Critical Illness; Post Intensive Care Syndrome; Post Intensive Care Syndrome Family

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (34)

• Frequency of PICS sub-domains

  up to 5 years

• Frailty status

  up to 5 years

• Post-Intensive Care Syndrome symptoms assessed by the PICS Questionnaire (PICSq)

  up to 5 years

• Physical function assessed by the Barthel Index

  up to 5 years

• Physical function assessed by the Timed Up-and-Go Test

  up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care unit patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Charite University, Berlin, Germany: collaborator
• University of Wuerzburg: collaborator
• University Hospital Augsburg: collaborator

Study Sites (4)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

NOT YET RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

NOT YET RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 31522829 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

Related Links

• Webpage of the PICS-DACH Consortium

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample may be collected by centers.

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

• Patrick Meybohm, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

• Philipp Simon, MD

  Universitätsklinikum Augsburg

  PRINCIPAL INVESTIGATOR

• Claudia Spies, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Christian Stoppe, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

• Manfred Weiss, MD

  Universitätsklinikum Augsburg

  PRINCIPAL INVESTIGATOR

• Marion Wiegele, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PICS-DACH Steering Committee

CONTACT

+4314040041020; pics-dach-sc@listserv.muv.ac.at

Study Coordination AAI MUV

CONTACT

aai-research@muv.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 18, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2035
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

DE (3); AU (1)