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NCT Number: NCT05984069

Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported

After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are not really known.

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Key information

Conditions

Post Intensive Care Syndrome Behavior Fatigue Frailty Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne, Saint-Etienne, France

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About this study

Frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a cause of post-ICU fatigue self-reported.

The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a length of stay in intensive care > or equal to 7 days, or mechanical ventilation > or equal to 5 days

Exclusion criteria

  • Scheduled surgery with admission in ICU
  • Pregnancy
  • Guardianship

Treatment and study plan

observational prospective data collection

Other

Collection of data from medical records.

Primary outcomes

  1. Frailty

    Time frame: 1 year

    Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported

Secondary outcomes

  1. Fatigue

    Time frame: 1 year

    Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort

  2. ICU-acquired weakness and fatigue

    Time frame: 1 year

    Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test

  3. Fatigue, quality of life, anxiety and depressive disorder

    Time frame: 1 year

    Correlation between fatigue, quality of life, anxiety and depressive disorder

  4. Kinetic of muscle mass loss and post-ICU fatigue self-reported

    Time frame: 1 year

    Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported

Study contacts

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

Jérôme MOREL, MD PhD

CONTACT

[email protected]

(0)477828553 ext. +33

Nory ELHADJENE, MD

CONTACT

[email protected]

(0)477828553 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: FICUF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
Mar 18, 2025

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.

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