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

NCT06671795 | Recruiting

• 2 other identifiers: SASICUPICS2012/2023101132808
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Intensive Care Syndrome (PICS)

Keywords

Post-Intensive Care Syndrome (PICS); ICU Biobank; Long-term ICU outcomes; Cognitive impairment; Physical impairment; Psychological impairment; Health-related quality of life (HRQoL); Epigenetics in critical care; ICU recovery clinic

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Pain and Discomfort using EQ-5D-5L

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

• Frailty Status using Clinical Frailty Scale

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ICU stay of at least 48 hours
• Age between 18 and 65 years at the time of ICU admission
• Written informed consent

You may not qualify if:

• Transfer from another ICU outside of the Medical University of Vienna
• Patient with a legal guardian
• Homelessness
• Place of residence outside of Austria

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The study will retain participant biospecimens, specifically blood samples, and these may be used to extract DNA to explore potential biomarkers related to Post-Intensive Care Syndrome (PICS) and other post-ICU outcomes.

MeSH Terms

Conditions

postintensive care syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Akos Tiboldi, Dr.med.univ.

CONTACT

+4314040041000; akos.tiboldi@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: January 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AU (1)