Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-rep... | NCT05984069

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

NCT05984069

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Recruiting

Last Update Posted

Mar 18, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Post Intensive Care Syndrome

Interventions

observational prospective data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 2, 2023

First Submission Date that Met QC Criteria

Aug 2, 2023

First Posted Date

Aug 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
observational prospective data collection	Other	Collection of data from medical records.	Patients on etiologies

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jérôme MOREL, MD PhD	Contact	(0)477828553	+33	jerome.morel@chu-st-etienne.fr
Nory ELHADJENE, MD	Contact	(0)477828553	+33	nory.saint-etienne@wanadoo.fr

Overall Officials

Name	Affiliation	Role
Jérôme MOREL, MD PhD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Saint-Etienne	Recruiting	Saint-Etienne		42000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000657744	postintensive care syndrome
D000073496	Frailty
D005221	Fatigue
D009043	Motor Activity

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012816	Signs and Symptoms
D001519	Behavior

Browse Leaves

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Browse Branches

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