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

N/ARecruitingNCT06671795

Medical University of Vienna400 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Post-Intensive Care Syndrome (PICS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 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.

Time frame: 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.

Time frame: 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.

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)

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.

Time frame: 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.

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)

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.

Time frame: 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)

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)

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).

Time frame: 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.

Time frame: 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.

Time frame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge

Secondary Outcomes

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 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.

Time frame: 4-5 weeks, 6 months and 10-12 months after ICU discharge

NCT06671795 - ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS) | Crick | Crick