Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06671795

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Post-Intensive Care Syndrome (PICS) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders postintensive care syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of PICS and its components

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

    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.

  2. 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

    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.

  3. Health-Related Quality of Life (HRQoL) using SF-36

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

    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.

  4. Cognitive Function using Montreal Cognitive Assessment (MoCA)

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

    Cognitive function measured by the MoCA, with scores below 24 indicating impairment. Only patients with prior normal cognitive function are eligible.

  5. 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

    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.

  6. Anxiety and Depression Symptoms using HADS

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

    Anxiety and depression symptoms measured with HADS. Subscale scores ≥8 indicate significant anxiety or depression.

  7. 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

    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.

  8. Physical Function using 6-Minute Walk Test (6MWT)

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

    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)

  9. 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

    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).

  10. Pulmonary Function - FEV1/FVC Ratio

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

    Pulmonary function assessed by FEV1/FVC ratio (Tiffeneau index); a value below the 5th percentile indicates obstructive ventilation disorder.

  11. Pulmonary Function using Total Lung Capacity (TLC)

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

    Pulmonary function assessed by total lung capacity (TLC), where values below the 5th percentile indicate a restrictive ventilation disorder.

Secondary outcomes

  1. Pain and Discomfort using EQ-5D-5L

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

    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

  2. Frailty Status using Clinical Frailty Scale

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Akos Tiboldi, Dr.med.univ.

CONTACT

[email protected]

+4314040041000

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.