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

NCT05984069 | Recruiting

• 1 other identifier: IRBN962022/CHUSTE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Intensive Care Syndrome

Keywords

Intensive Care Unit; frailty; fatigue; ICU acquired-weakness; FACIT-F; physical activity

Outcome Measures

Primary Outcomes (1)

• Frailty

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

  1 year

Secondary Outcomes (4)

• Fatigue

  1 year

• ICU-acquired weakness and fatigue

  1 year

• Fatigue, quality of life, anxiety and depressive disorder

  1 year

• Kinetic of muscle mass loss and post-ICU fatigue self-reported

  1 year

Study Arms (1)

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

Interventions

observational prospective data collection OTHER

Collection of data from medical records.

Patients on etiologies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with a length of stay in intensive care \> or equal to 7 days, or mechanical ventilation \> or equal to 5 days

You may not qualify if:

• Scheduled surgery with admission in ICU
• Pregnancy
• Guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Chu Saint-Etienne

Saint-Etienne, 42000, France

RECRUITING

Hôpital Privé de la Loire

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Frailty; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Jérôme MOREL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme MOREL, MD PhD

CONTACT

(0)477828553; jerome.morel@chu-st-etienne.fr

Nory ELHADJENE, MD

CONTACT

(0)477828553; nory.saint-etienne@wanadoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: July 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)