Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-20 @ 10:43 PM
Study NCT ID:
NCT03326635
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}, {'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)', 'timeFrame': 'One month or 15 patients ≥ 70 years old', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Organ failures', 'timeFrame': 'About 8 days', 'description': "During the patients' hospitalization in ICU, the following data were collected last day in ICU:\n\nthe 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)"}, {'measure': 'Nutritional support', 'timeFrame': 'About 8 days', 'description': "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:\n\nnumber of days under enteral nutrition number of days under enteral parenteral nutrition calculation of the average calorie / day"}, {'measure': 'Rehabilitation', 'timeFrame': 'About 8 days', 'description': '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.'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'ICU mortality and Hospital mortality Decision of therapeutics limitation. Length of stay (ICU and hospital stay).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resuscitation', 'Frailty', 'ICU', 'Ageing', 'Rehabilitation', 'Elderly'], 'conditions': ['Resuscitation']}, 'descriptionModule': {'briefSummary': "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.\n\nIt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 70 year-old admitted to an ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 70 year-old\n* Prevision of a length of stay \\> 24 hrs.\n* Patient or relative who received information about the study and did not oppose it\n\nExclusion Criteria:\n\n* Life expectancy \\< 24 hrs\n* Patients unable to communicate and no next of kin available.\n* adults, non-emancipated minors, persons unable to receive information,\n* persons placed under the safeguard of justice,\n* subject participating in another search including an exclusion period still in progress at pre-inclusion'}, 'identificationModule': {'nctId': 'NCT03326635', 'acronym': 'FRAGIREA', 'briefTitle': 'Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.', 'orgStudyIdInfo': {'id': '69HCL17_0017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'frailty group', 'description': 'frailty score ≤ 3', 'interventionNames': ['Other: Frailty in elderly (≥70 y) patients in ICU']}, {'label': 'non-frailty group', 'description': 'frailty score \\>3', 'interventionNames': ['Other: Frailty in elderly (≥70 y) patients in ICU']}], 'interventions': [{'name': 'Frailty in elderly (≥70 y) patients in ICU', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['frailty group', 'non-frailty group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'CH Aix en Provence', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Annonay', 'country': 'France', 'facility': 'CH Annonay', 'geoPoint': {'lat': 45.23992, 'lon': 4.6707}}, {'city': 'Argenteuil', 'country': 'France', 'facility': 'CH Argentueil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Belfort', 'country': 'France', 'facility': 'CH Belfort', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'city': 'Béziers', 'country': 'France', 'facility': 'CH Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'CH Bourg en Bresse', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Bourgoin', 'country': 'France', 'facility': 'CH Bourgoin-Jallieu', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'CH Chalons sur Saône', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'CH Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Évry', 'country': 'France', 'facility': 'CH Sud Francilien', 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}, {'city': 'La Tronche', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot, G Réa', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot, N réa', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot, P Réa', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69005', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montauban', 'country': 'France', 'facility': 'CH Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'city': 'Montélimar', 'country': 'France', 'facility': 'CH Montélimar', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'city': 'Moulins', 'country': 'France', 'facility': 'CH Moulins', 'geoPoint': {'lat': 46.56459, 'lon': 3.33243}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud Réa Nord', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Denis', 'country': 'France', 'facility': 'CH Saint Denis', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Salon-de-Provence', 'country': 'France', 'facility': 'CH Salons de Provence', 'geoPoint': {'lat': 43.64229, 'lon': 5.09478}}, {'city': 'Valence', 'country': 'France', 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'city': 'Vichy', 'country': 'France', 'facility': 'CH Vichy', 'geoPoint': {'lat': 46.12709, 'lon': 3.42577}}, {'city': 'Mayotte', 'country': 'Mayotte', 'facility': 'CH Mayotte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}