Prospective, observational, monocentric study to identify risk factors and incidence of the Post-Intensive Care Syndrome (PICS) during and after treatment in the intensive care unit

Prospective, observational, monocentric study to identify risk factors and incidence of the Post-Intensive Care Syndrome (PICS) during and after treatment in the intensive care unit - PICS-II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034741

Enrollment

5000

Registered

2025-03-13

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any cognitive, physical, and psychological impairment that is associated with an ICU stay or is suspected to be associated with it.

Interventions

Group 1: This study involves adult patients who are admitted to the Intensive Care Unit (ICU) of - the University Hospital of Augsburg - the University Hospital of Würzburg (Germany) - the Charité –

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) All patients admitted to the ICUs of participating university hospitals for at least 72 hours between February 2025 and (at least) February 2029, and who are treated during this period. 2) Written informed consent by the patient or legal proxy (spouse or consular physician procedure), and for the PICS-F module, consent from the family members.

Exclusion criteria

Exclusion criteria: Patients who, at the time of screening, are receiving end-of-life care or for whom treatment withdrawal or failure is highly likely, or for whom the treatment team does not expect survival beyond the ICU stay.

Design outcomes

Primary

Measure	Time frame
Diagnosis of PICS based on at least one abnormality in one of the domains (physical, psychological, cognitive, pain) at least at one measurement time point.	—

Secondary

Measure	Time frame
- Incidence of PICS in ICU patients and PICS-F (Family System) including the temporal progression. - Correlation between the occurrence of PICS criteria and PICS after treatment in an ICU with detected risk factors. - Incidence of PICS criteria in individual or multiple PICS dimensions (physical, cognitive, psychological, chronic pain), as well as similar impairments during the ICU stay. - Severity of PICS criteria in individual or multiple PICS dimensions (physical, cognitive, psychological, pain), as well as similar impairments during the ICU stay. - Risk classification for PICS (e.g., using the Pareto principle or classification into low, medium, and high-risk groups) based on scoring systems.	—

Measure

Time frame

- Incidence of PICS in ICU patients and PICS-F (Family System) including the temporal progression. - Correlation between the occurrence of PICS criteria and PICS after treatment in an ICU with detected risk factors. - Incidence of PICS criteria in individual or multiple PICS dimensions (physical, cognitive, psychological, chronic pain), as well as similar impairments during the ICU stay. - Severity of PICS criteria in individual or multiple PICS dimensions (physical, cognitive, psychological, pain), as well as similar impairments during the ICU stay. - Risk classification for PICS (e.g., using the Pareto principle or classification into low, medium, and high-risk groups) based on scoring systems.

—

Countries

Austria, Germany

Contacts

Public ContactManfred Weiß

Universtitätsklinikum Augsburg

manfred.weiss@uk-augsburg.de49 821 400 165292

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026