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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 25, 2019

Interventions

  • 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

Arms, Groups and Cohorts

  • frailty group
    • frailty score ≤ 3
  • non-frailty group
    • frailty score >3

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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)
  • 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
  • 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.
  • Mortality
    • Time Frame: 90 days
    • ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

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