ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post-Intensive Care Syndrome (PICS). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome
Overview
The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours. The main questions it aims to answer are: What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function? Participants will: Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge. Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function. Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress. This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.
Primary outcome measures
- Incidence of PICS and its components [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Health-related quality of life (HRQoL) using EQ-5D-5L [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Health-Related Quality of Life (HRQoL) using SF-36 [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Cognitive Function using Montreal Cognitive Assessment (MoCA) [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Anxiety and Depression Symptoms using HADS [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R) [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Physical Function using 6-Minute Walk Test (6MWT) [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx) [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Pulmonary Function - FEV1/FVC Ratio [Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
Secondary outcome measures (2)
- Pain and Discomfort using EQ-5D-5L [Time frame: 4-5 weeks, 6 months and 10-12 months after ICU discharge]
- Frailty Status using Clinical Frailty Scale [Time frame: 4-5 weeks, 6 months and 10-12 months after ICU discharge]
Eligibility criteria
Inclusion criteria
- ICU stay of at least 48 hours
- Age between 18 and 65 years at the time of ICU admission
- Written informed consent
Exclusion criteria
- Transfer from another ICU outside of the Medical University of Vienna
- Patient with a legal guardian
- Homelessness
- Place of residence outside of Austria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT06671795 · SASICUPICS2012/2023 · 101132808