ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)

Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Intensive Care Syndrome (PICS)

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Akos Tiboldi, Dr.med.univ.; Phone Number: +4314040041000; Email: akos.tiboldi@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Akos Tiboldi, Dr.med.univ.; Phone Number: +4314040041000; Email: akos.tiboldi@meduniwien.ac.at
    • Contact: Oliver Kimberger, Univ. Prof. Dr.; Phone Number: +4314040041000; Email: oliver.kimberger@meduniwien.ac.at
    • Contact: Akos Tiboldi, Dr.med.univ.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
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.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
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.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
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.	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)	Cognitive decline assessed with IQCODE, a validated informant questionnaire. Scores range from 1 (much improved) to 5 (much worse), with a cutoff average score of ≥3.31 indicating cognitive decline.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Anxiety and Depression Symptoms using HADS	Anxiety and depression symptoms measured with HADS. Subscale scores ≥8 indicate significant anxiety or depression.	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)	PTSD symptoms measured with the IES-R. Scores range from 0 (not at all) to 4 (extremely), with an average score of ≥1.6 indicating clinically significant PTSD symptoms.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical Function using 6-Minute Walk Test (6MWT)	Deterioration in the 6-Minute Walking Test (6-MWT) defined as a change in the target value of the walking distance calculated using the following equation: 218 + (5,14 x height - 5,32 x age) - 1,8 x weight + 51,31 x gender (height in cm, age in years, weight in kg, female 0 / male 1)	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx)	Physical function measured by CPAx, assessing various functional activities (grip strength, respiratory function, moving, sitting, standing, transferring, and stepping). Each domain is scored from 0 to 5, with an overall score from 0 (dependent) to 50 (fully independent).	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary Function - FEV1/FVC Ratio	Pulmonary function assessed by FEV1/FVC ratio (Tiffeneau index); a value below the 5th percentile indicates obstructive ventilation disorder.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary Function using Total Lung Capacity (TLC)	Pulmonary function assessed by total lung capacity (TLC), where values below the 5th percentile indicate a restrictive ventilation disorder.	at 4-5 weeks, 6 months and 10-12 months after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4-5 weeks, 6 months and 10-12 months after ICU discharge
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.	4-5 weeks, 6 months and 10-12 months after ICU discharge

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Health-related quality of life (HRQoL); Cognitive impairment; Physical impairment; Post-Intensive Care Syndrome (PICS); ICU Biobank; Long-term ICU outcomes; Psychological impairment; Epigenetics in critical care; ICU recovery clinic
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: SASICUPICS2012/2023; 101132808 (Other Grant/Funding Number: Innovative Health Initiative Joint Undertaking (IHI JU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study plans to share de-identified individual participant data (IPD) with other researchers to facilitate additional research on Post-Intensive Care Syndrome (PICS). Shared data will include information related to health outcomes, quality of life assessments, and biomarker findings. Access will be granted through a controlled database managed by the Medical University of Vienna, upon reasonable request and approval by the study's ethics board.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No