Clinical trial NCT06671795: ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)
Official title: Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PICS and its components
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Health-related quality of life (HRQoL) using EQ-5D-5L
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Health-Related Quality of Life (HRQoL) using SF-36
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Cognitive Function using Montreal Cognitive Assessment (MoCA)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Anxiety and Depression Symptoms using HADS
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Physical Function using 6-Minute Walk Test (6MWT)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Pulmonary Function - FEV1/FVC Ratio
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Pulmonary Function using Total Lung Capacity (TLC)
timeFrame: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Secondary outcomes:
measure: Pain and Discomfort using EQ-5D-5L
timeFrame: 4-5 weeks, 6 months and 10-12 months after ICU discharge
measure: Frailty Status using Clinical Frailty Scale
timeFrame: 4-5 weeks, 6 months and 10-12 months after ICU discharge
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: