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

Post Intensive Care Syndrome Clinical Trial

— FICUF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984069
• Other study ID #: IRBN962022/CHUSTE
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jérôme MOREL, MD PhD
• Phone: (0)477828553
• Email: jerome.morel[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Frailty
• Post Intensive Care Syndrome

Intervention

Other:
• observational prospective data collection
Collection of data from medical records.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne
France	Hôpital Privé de la Loire	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty	Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported	1 year
Secondary	Fatigue	Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort	1 year
Secondary	ICU-acquired weakness and fatigue	Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test	1 year
Secondary	Fatigue, quality of life, anxiety and depressive disorder	Correlation between fatigue, quality of life, anxiety and depressive disorder	1 year
Secondary	Kinetic of muscle mass loss and post-ICU fatigue self-reported	Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported	1 year