Clinical trial NCT03326635: Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
Official title: Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resuscitation
Keywords: Resuscitation
Frailty
ICU
Ageing
Rehabilitation
Elderly
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 527
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 70 year-old admitted to an ICU.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)
timeFrame: One month or 15 patients ≥ 70 years old
Secondary outcomes:
measure: Organ failures
timeFrame: About 8 days
measure: Nutritional support
timeFrame: About 8 days
measure: Rehabilitation
timeFrame: About 8 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CH Aix en Provence
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH Annecy
city: Annonay
country: France
facility: CH Annonay
city: Argenteuil
country: France
facility: CH Argentueil
city: Belfort
country: France
facility: CH Belfort
city: Bourg-en-Bresse
country: France
facility: CH Bourg en Bresse
city: Bourgoin-Jallieu
country: France
facility: CH Bourgoin-Jallieu
city: Béziers
country: France
facility: CH Béziers
city: Chalon-sur-Saône
country: France
facility: CH Chalons sur Saône
city: Chambéry
country: France
facility: CH Chambéry
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: La Tronche
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hôpital Edouard Herriot, G Réa
city: Lyon
country: France
facility: Hôpital Edouard Herriot, N réa
city: Lyon
country: France
facility: Hôpital Edouard Herriot, P Réa
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Marseille
country: France
facility: AP-HM La Timone
city: Montauban
country: France
facility: CH Montauban
city: Montélimar
country: France
facility: CH Montélimar
city: Moulins
country: France
facility: CH Moulins
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud Réa Nord
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Denis
country: France
facility: CH Saint Denis
city: Saint-Étienne
country: France
facility: CHU Hôpital Nord
city: Salon-de-Provence
country: France
facility: CH Salons de Provence
city: Valence
country: France
facility: CH Valence
city: Vichy
country: France
facility: CH Vichy
city: Évry
country: France
facility: CH Sud Francilien
city: Mayotte
country: Mayotte
facility: CH Mayotte
Study officials:
References: