FICUF: Impact of Frailty on Post-ICU Fatigue Self-reported

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05984069
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Intensive Care Syndrome	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 and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Frailty on Post-ICU Fatigue Self-reported
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Frailty [1 year]

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

Secondary Outcome Measures

1. Fatigue [1 year]

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

2. ICU-acquired weakness and fatigue [1 year]

   Relationship between post-ICU fatigue self-reported and ICU-acquired weakness

3. Correlation between fatigue, quality of life, anxiety and depressive disorder [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint-etienne		France	42000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Jérôme MOREL, MD PhD, CHU Saint Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT05984069
• Other Study ID Numbers: IRBN962022/CHUSTE
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Intensive Care Unit; frailty; fatigue; ICU acquired-weakness; FACIT-F; physical activity
• Additional relevant MeSH terms: Fatigue; Frailty

Study Results

No Results Posted as of Aug 9, 2023