Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05984069
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000657744', 'term': 'postintensive care syndrome'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty', 'timeFrame': '1 year', 'description': 'Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '1 year', 'description': 'Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort'}, {'measure': 'ICU-acquired weakness and fatigue', 'timeFrame': '1 year', 'description': 'Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test'}, {'measure': 'Fatigue, quality of life, anxiety and depressive disorder', 'timeFrame': '1 year', 'description': 'Correlation between fatigue, quality of life, anxiety and depressive disorder'}, {'measure': 'Kinetic of muscle mass loss and post-ICU fatigue self-reported', 'timeFrame': '1 year', 'description': 'Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Unit', 'frailty', 'fatigue', 'ICU acquired-weakness', 'FACIT-F', 'physical activity'], 'conditions': ['Post Intensive Care Syndrome']}, 'descriptionModule': {'briefSummary': 'After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are not really known.', 'detailedDescription': 'Frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a cause of post-ICU fatigue self-reported.\n\nThe aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to intensive care, all etiologies combined, excluding immediate post-operative scheduled surgery, with mechanical ventilation for more than 5 days or length of stay in ICU over 10 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a length of stay in intensive care \\> or equal to 7 days, or mechanical ventilation \\> or equal to 5 days\n\nExclusion Criteria:\n\n* Scheduled surgery with admission in ICU\n* Pregnancy\n* Guardianship'}, 'identificationModule': {'nctId': 'NCT05984069', 'acronym': 'FICUF', 'briefTitle': 'Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported', 'orgStudyIdInfo': {'id': 'IRBN962022/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on etiologies', 'description': 'Patients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included', 'interventionNames': ['Other: observational prospective data collection']}], 'interventions': [{'name': 'observational prospective data collection', 'type': 'OTHER', 'description': 'Collection of data from medical records.', 'armGroupLabels': ['Patients on etiologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme MOREL, MD PhD', 'role': 'CONTACT', 'email': 'jerome.morel@chu-st-etienne.fr', 'phone': '(0)4 77 82 85 53', 'phoneExt': '+33'}, {'name': 'Jérôme MOREL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nory ELHADJENE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent GERGELE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benoît CREMILLIEUX, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Privé de la Loire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Jérôme MOREL, MD PhD', 'role': 'CONTACT', 'email': 'jerome.morel@chu-st-etienne.fr', 'phone': '(0)477828553', 'phoneExt': '+33'}, {'name': 'Nory ELHADJENE, MD', 'role': 'CONTACT', 'email': 'nory.saint-etienne@wanadoo.fr', 'phone': '(0)477828553', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Jérôme MOREL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}