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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome
• Intervention / Treatment: Other: observational prospective data collection

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jérôme MOREL, MD PhD; Phone Number: +33 (0)477828553; Email: jerome.morel@chu-st-etienne.fr
• Study Contact Backup: Name: Nory ELHADJENE, MD; Phone Number: +33 (0)477828553; Email: nory.saint-etienne@wanadoo.fr

Study Locations

• France
  • Saint-etienne, France, 42000
    • Recruiting
    • Chu Saint-Etienne
    • Contact: Jérôme MOREL, MD PhD; Phone Number: +33 (0)4 77 82 85 53; Email: jerome.morel@chu-st-etienne.fr
    • Principal Investigator: Jérôme MOREL, MD PhD
    • Sub-Investigator: Nory ELHADJENE, MD
  • Saint-Étienne, France
    • Recruiting
    • Hôpital Privé de la Loire
    • Principal Investigator: Laurent GERGELE, MD
    • Sub-Investigator: Benoît CREMILLIEUX, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to intensive care, all etiologies combined, excluding immediate post-operative scheduled surgery, with mechanical ventilation for more than 5 days or length of stay in ICU over 10 days.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients on etiologies; 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	Other: observational prospective data collection; Collection of data from medical records.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort	1 year
ICU-acquired weakness and fatigue	Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test	1 year
Fatigue, quality of life, anxiety and depressive disorder	Correlation between fatigue, quality of life, anxiety and depressive disorder	1 year
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jérôme MOREL, MD PhD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; fatigue; frailty; Intensive Care Unit; FACIT-F; ICU acquired-weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Fatigue
• Other Study ID Numbers: IRBN962022/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No