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NCT05984069 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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