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Recruiting NCT05984069

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

Observational Post Intensive Care Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational prospective data collection.
Who it may be relevant to
Registry conditions: Post Intensive Care Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other observational prospective data collection
    Collection of data from medical records.

Primary outcome measures

  • Frailty [Time frame: 1 year]
Secondary outcome measures (4)
  • Fatigue [Time frame: 1 year]
  • ICU-acquired weakness and fatigue [Time frame: 1 year]
  • Fatigue, quality of life, anxiety and depressive disorder [Time frame: 1 year]
  • Kinetic of muscle mass loss and post-ICU fatigue self-reported [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Chu Saint-Etienne — Saint-Etienne
  • Hôpital Privé de la Loire — Saint-Etienne

Identifiers

NCT: NCT05984069 · IRBN962022/CHUSTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗