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

NCT ID: NCT06671795

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-28

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Intensive Care Syndrome (PICS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Akos Tiboldi

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Akos Tiboldi, Dr.med.univ.

Role: CONTACT

+4314040041000

Facility Contacts

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Akos Tiboldi, Dr.med.univ.

Role: primary

+4314040041000

Oliver Kimberger, Univ. Prof. Dr.

Role: backup

+4314040041000

Akos Tiboldi, Dr.med.univ.

Role: backup

Other Identifiers

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101132808

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SASICUPICS2012/2023

Identifier Type: -

Identifier Source: org_study_id

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