Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty. (FRAGIREA)

August 13, 2019 updated by: Hospices Civils de Lyon

Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. The voluntary ICUs will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the ICU, based on informations given by the patient's family.

It is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in ICUs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

527

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • CH Aix en Provence
      • Angers, France
        • CHU Angers
      • Annecy, France
        • CH Annecy
      • Annonay, France
        • Ch Annonay
      • Argenteuil, France
        • CH Argentueil
      • Belfort, France
        • CH Belfort
      • Bourg-en-Bresse, France
        • CH Bourg en Bresse
      • Bourgoin-Jallieu, France
        • CH Bourgoin-Jallieu
      • Béziers, France
        • CH Beziers
      • Chalon-sur-Saône, France
        • CH Chalons sur Saône
      • Chambéry, France
        • CH Chambery
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • La Tronche, France
        • CHU Grenoble
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, G Réa
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, N réa
      • Lyon, France, 69003
        • Hôpital Edouard Herriot, P Réa
      • Lyon, France, 69005
        • Hopital de La Croix Rousse
      • Marseille, France
        • AP-HM Hôpital Nord
      • Marseille, France
        • AP-HM La Timone
      • Montauban, France
        • CH Montauban
      • Montélimar, France
        • CH Montélimar
      • Moulins, France
        • CH Moulins
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU Nice
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud Réa Nord
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • CHU Rennes
      • Rennes, France
        • CHU de Rennes
      • Rouen, France
        • CHU Rouen
      • Saint-Denis, France
        • CH Saint Denis
      • Saint-Étienne, France
        • CHU Hôpital Nord
      • Salon-de-Provence, France
        • CH Salons de Provence
      • Valence, France
        • CH Valence
      • Vichy, France
        • CH Vichy
      • Évry, France
        • CH SUd Francilien
  • Mayotte
      • Mayotte, Mayotte
        • CH Mayotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ≥ 70 year-old admitted to an ICU.

Description

Inclusion Criteria:

  • ≥ 70 year-old
  • Prevision of a length of stay > 24 hrs.
  • Patient or relative who received information about the study and did not oppose it

Exclusion Criteria:

  • Life expectancy < 24 hrs
  • Patients unable to communicate and no next of kin available.
  • adults, non-emancipated minors, persons unable to receive information,
  • persons placed under the safeguard of justice,
  • subject participating in another search including an exclusion period still in progress at pre-inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
frailty group
frailty score ≤ 3
Other: Frailty in elderly (≥70 y) patients in ICU
Determine the prevalence of frailty in elderly patients (≥ 70 year old) in a group of French ICUs. The frailty is measured by a score (Fried score) at the admission of the patient
non-frailty group
frailty score >3
Other: Frailty in elderly (≥70 y) patients in ICU
Determine the prevalence of frailty in elderly patients (≥ 70 year old) in a group of French ICUs. The frailty is measured by a score (Fried score) at the admission of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)
Time Frame: One month or 15 patients ≥ 70 years old
We assessed the 5 components of Fried's frailty index, resulting from cumulative decline across multiple physiological systems and contain five criteria (shrinking, weakness, slowness, low-level physical activity, and self-reported exhaustion). All five components were considered from the previously reported definition and adapted to the ICU environment. The patients were considered to be frail if they had three or more frailty components among the five criteria.
One month or 15 patients ≥ 70 years old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ failures
Time Frame: About 8 days

During the patients' hospitalization in ICU, the following data were collected last day in ICU:

the need for dialysis during ICU the duration of mechanical ventilation (number of days under mechanical ventilation) the duration of shock (number of days under catecholamines)
About 8 days
Nutritional support
Time Frame: About 8 days

Nutritional intake during ICU stay, from the first day to the patient's exit, including route of administration (enteral, parenteral), last day in ICU we assessed:

number of days under enteral nutrition number of days under enteral parenteral nutrition calculation of the average calorie / day
About 8 days
Rehabilitation
Time Frame: About 8 days
Last day in ICU, we record the highest level of mobilization achieved during the ICU period, the following ordinal scale was used: 1) no mobilization, 2) turning in bed, 3) sitting in bed with the head of bed elevated, 4) sitting on the edge of the bed with feet on floor, 5) sitting out of bed in a chair, 6) standing out of bed, 7) marching in place, 8) walking, 9) using cycloergometer and 9) using electrical muscle stimulation.
About 8 days
Mortality
Time Frame: 90 days
ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2018

Primary Completion (Actual)

January 25, 2019

Study Completion (Actual)

July 24, 2019

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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