ResuscitationFRAGIREANCT03326635
Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
An observational study of Resuscitation, run by Hospices Civils de Lyon at 37 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Resuscitation
- What is being tested?
- Frailty in elderly (≥70 y) patients in ICU
- How many people
- 527 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 8 Apr 2018to 24 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥ 70 year-old admitted to an ICU.
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
France36 sites
CH Aix en Provence
Aix-en-Provence
CHU Angers
Angers
CH Annecy
Annecy
CH Annonay
Annonay
CH Argentueil
Argenteuil
CH Belfort
Belfort
CH Béziers
Béziers
CH Bourg en Bresse
Bourg-en-Bresse
CH Bourgoin-Jallieu
Bourgoin
CH Chalons sur Saône
Chalon-sur-Saône
CH Chambéry
Chambéry
CHU Clermont-Ferrand
Clermont-Ferrand
CH Sud Francilien
Évry
CHU Grenoble
La Tronche
Hôpital Edouard Herriot, G Réa
Lyon, 69003
Hôpital Edouard Herriot, N réa
Lyon, 69003
Hôpital Edouard Herriot, P Réa
Lyon, 69003
Hôpital de la Croix Rousse
Lyon, 69005
AP-HM Hôpital Nord
Marseille
AP-HM La Timone
Marseille
CH Montauban
Montauban
CH Montélimar
Montélimar
CH Moulins
Moulins
CHU Nantes
Nantes
CHU Nice
Nice
Centre Hospitalier Lyon Sud Réa Nord
Pierre-Bénite, 69495
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU Poitiers
Poitiers
CHU de Rennes
Rennes
CHU Rennes
Rennes
CHU Rouen
Rouen
CH Saint Denis
Saint-Denis
CHU Hôpital Nord
Saint-Etienne
CH Salons de Provence
Salon-de-Provence
CH Valence
Valence
CH Vichy
Vichy
Mayotte1 site
CH Mayotte
Mayotte
About this study
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.
- Conditions
- Resuscitation
- Being tested
- Frailty in elderly (≥70 y) patients in ICU
- Keywords
- Resuscitation, Frailty, ICU, Ageing, Rehabilitation, Elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty in elderly (≥70 y) patients in ICUOther
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
| Study group | Role | What they receive |
|---|---|---|
| frailty group | frailty score ≤ 3 Receives: Other: Frailty in elderly (≥70 y) patients in ICU | |
| non-frailty group | frailty score >3 Receives: Other: Frailty in elderly (≥70 y) patients in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)
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.
Measured: One month or 15 patients ≥ 70 years old
Secondary outcomes (4)
Organ failures
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)
Measured: About 8 days
Nutritional support
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
Measured: About 8 days
Rehabilitation
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.
Measured: About 8 days
Mortality
ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start8 Apr 2018
- Primary completion25 Jan 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326635
- Sponsor's protocol ID
- 69HCL17_0017
- Acronym
- FRAGIREA
- Status last verified
- Aug 2019
- First submitted
- 17 Oct 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
- ClinicalTrials.gov ID
- NCT03326635
- Acronym / sponsor ID
- FRAGIREA / 69HCL17_0017
- Conditions
- Resuscitation
- Keywords
- Resuscitation, Frailty, ICU, Ageing, Rehabilitation, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frailty group | – | Other: Frailty in elderly (≥70 y) patients in ICUfrailty score ≤ 3 |
| non-frailty group | – | Other: Frailty in elderly (≥70 y) patients in ICUfrailty score >3 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥ 70 year-old admitted to an ICU.
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty in elderly (≥70 y) patients in ICUDetermine 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 | Other | frailty group, non-frailty group |
Primary outcome
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.
4 secondary outcomes
Organ failures
Time frame: About 8 days
Nutritional support
Time frame: About 8 days
Rehabilitation
Time frame: About 8 days
Mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation, run by Hospices Civils de Lyon at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Mayotte. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU) (time frame: One month or 15 patients ≥ 70 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.