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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03326635
Acronym
FRAGIREA
Enrollment
527
Registered
2017-10-31
Start date
2018-04-08
Completion date
2019-07-24
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resuscitation

Keywords

Resuscitation, Frailty, ICU, Ageing, Rehabilitation, Elderly

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.

Interventions

OTHERFrailty 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)One month or 15 patients ≥ 70 years oldWe 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

MeasureTime frameDescription
Organ failuresAbout 8 daysDuring 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 supportAbout 8 daysNutritional 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
RehabilitationAbout 8 daysLast 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.
Mortality90 daysICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).

Countries

France, Mayotte

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026