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

NCT ID: NCT07290712

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2035-11-01

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.

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Wuerzburg

OTHER

Sponsor Role: collaborator

University Hospital Augsburg

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Stefan Schaller

Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vieanna

Bjoern Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Claudia Denke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Patrick Meybohm, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Philipp Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Augsburg

Claudia Spies, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Christian Stoppe, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Manfred Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Augsburg

Marion Wiegele, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Countries

Austria; Germany

Central Contacts

PICS-DACH Steering Committee

Role: CONTACT

Phone: +4314040041020

Email: pics-dach-sc@listserv.muv.ac.at

Study Coordination AAI MUV

Role: CONTACT

Email: aai-research@muv.ac.at

Facility Contacts

Stefan J Schaller, MD

Role: primary

Marion Wiegele, MD

Role: backup

Philipp Simon, MD

Role: primary

Manfred Weiss, MD

Role: backup

Patrick Meybohm, MD

Role: primary

Christian Stoppe, MD

Role: backup

Claudia Spies, MD

Role: primary

Claudia Denke, Dr.

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31522829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16129869 (View on PubMed)

Related Links

https://www.pics-dach.eu

Webpage of the PICS-DACH Consortium

Other Identifiers

PICS-DACH

Identifier Type: -

Identifier Source: org_study_id