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

Completed

• Conditions: Resuscitation
• Interventions: Other: Frailty in elderly (≥70 y) patients in ICU

• Registration Number: NCT03326635
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Study Start: 2018-04-08
• Primary Completion: 2019-01-25
• Study Completion: 2019-07-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
frailty group	Frailty in elderly (≥70 y) patients in ICU	frailty score ≤ 3
non-frailty group	Frailty in elderly (≥70 y) patients in ICU	frailty score \>3

Primary Outcome Measures

Name	Time	Method
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)	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.

Secondary Outcome Measures

Name	Time	Method
Organ failures	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)
Nutritional support	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
Rehabilitation	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.
Mortality	90 days	ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).

Trial Locations

Locations (37)

CH Bourg en Bresse; 🇫🇷 Bourg-en-Bresse, France

Hôpital Edouard Herriot, P Réa; 🇫🇷 Lyon, France

CHU Angers; 🇫🇷 Angers, France

CH Annonay; 🇫🇷 Annonay, France

CH Bourgoin-Jallieu; 🇫🇷 Bourgoin-Jallieu, France

CH Béziers; 🇫🇷 Béziers, France

CH Montélimar; 🇫🇷 Montélimar, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CH Annecy; 🇫🇷 Annecy, France

CH Argentueil; 🇫🇷 Argenteuil, France

CH Belfort; 🇫🇷 Belfort, France

AP-HM Hôpital Nord; 🇫🇷 Marseille, France

CH Moulins; 🇫🇷 Moulins, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France

CH Aix en Provence; 🇫🇷 Aix-en-Provence, France

CH Chalons sur Saône; 🇫🇷 Chalon-sur-Saône, France

Hôpital Edouard Herriot, G Réa; 🇫🇷 Lyon, France

Hôpital Edouard Herriot, N réa; 🇫🇷 Lyon, France

CH Montauban; 🇫🇷 Montauban, France

Centre Hospitalier Lyon Sud Réa Nord; 🇫🇷 Pierre-Bénite, France

CH Chambéry; 🇫🇷 Chambéry, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

CHU Grenoble; 🇫🇷 La Tronche, France

AP-HM La Timone; 🇫🇷 Marseille, France

CHU Nice; 🇫🇷 Nice, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU de 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, France

CH Sud Francilien; 🇫🇷 Évry, France

CH Mayotte; 🇾🇹 Mayotte, Mayotte