ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)
ConditionPost-Intensive Care Syndrome (PICS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ICU stay of at least 48 hours
Age between 18 and 65 years at the time of ICU admission
Written informed consent
Disqualifiers
Transfer from another ICU outside of the Medical University of Vienna
Patient with a legal guardian
Homelessness
Place of residence outside of Austria
Trial population
The study population consists of adult patients aged 18 to 65 who have been admitted to the Intensive Care Unit (ICU) at the Department of Anesthesia, Intensive Care Medicine, and Pain Medicine at the Medical University of Vienna. Participants are selected based on an ICU stay of at least 48 hours and must provide written informed consent. Patients transferred from other ICUs, those with legal guardians, individuals experiencing homelessness, or those residing outside of Austria are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of PICS and its components
Incidence of Post-Intensive Care Syndrome (PICS), defined as new or worsened impairments in physical, cognitive, or mental function persisting beyond hospital stay. Patients scoring above/below predefined cut-offs on any of the assessments (detailed below) will be diagnosed with PICS.
Time frame
at 4-5 weeks, 6 months and 10-12 months after ICU discharge2
Health-related quality of life (HRQoL) using EQ-5D-5L
a. The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category.
Time frame
at 4-5 weeks, 6 months and 10-12 months after ICU discharge3
Health-Related Quality of Life (HRQoL) using SF-36
HRQoL assessed with SF-36, covering eight health domains. Results will be aggregated into two composite scores: Physical Component Summary (PCS) and Mental Component Summary (MCS), with higher scores indicating a more favorable health state.
Time frame
at 4-5 weeks, 6 months and 10-12 months after ICU discharge4
Cognitive Function using Montreal Cognitive Assessment (MoCA)
Cognitive function measured by the MoCA, with scores below 24 indicating impairment. Only patients with prior normal cognitive function are eligible.
Time frame
at 4-5 weeks, 6 months and 10-12 months after ICU dischargeSecondary outcomes
1
Pain and Discomfort using EQ-5D-5L
The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category
Time frame
4-5 weeks, 6 months and 10-12 months after ICU discharge2
Frailty Status using Clinical Frailty Scale
Frailty measured by the Clinical Frailty Scale, with scores ranging from 1 (very fit) to 9 (terminally ill). Scores of 1-4 are classified as non-frail; 5-9 as frail.
Time frame
4-5 weeks, 6 months and 10-12 months after ICU dischargeSponsors and contacts
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Source ClinicalTrials.gov