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

Recruiting

• Conditions: Post Intensive Care Syndrome
• Interventions: Other: observational prospective data collection

• Registration Number: NCT05984069
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on etiologies	observational prospective data collection	Patients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included

Primary Outcome Measures

Name	Time	Method
Frailty	1 year	Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported

Secondary Outcome Measures

Name	Time	Method
Kinetic of muscle mass loss and post-ICU fatigue self-reported	1 year	Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported
ICU-acquired weakness and fatigue	1 year	Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test
Fatigue, quality of life, anxiety and depressive disorder	1 year	Correlation between fatigue, quality of life, anxiety and depressive disorder
Fatigue	1 year	Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort

Trial Locations

Locations (2)

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France

Hôpital Privé de la Loire; 🇫🇷 Saint-Étienne, France