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Completed

NCT Number: NCT03326635

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Aix en Provence, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty in elderly (≥70 y) patients in ICU

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. 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.

  4. Mortality

    Time frame: 90 days

    ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FRAGIREA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2017
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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