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

Resuscitation Clinical Trial

— FRAGIREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326635
• Other study ID #: 69HCL17_0017
• Status: Completed
• Start date: April 8, 2018
• Est. completion date: July 24, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: July 24, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Resuscitation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Mayotte, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty in elderly (=70 years old) patients in intensive care unit (ICU)	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	Organ failures	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
Secondary	Nutritional support	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
Secondary	Rehabilitation	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
Secondary	Mortality	ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).	90 days