Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05928767
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To show that the frailty score on admission is a risk factor for mortality at D28, independent of known risk factors, in young patients admitted to intensive care (ICU) for sepsis or septic shock.', 'timeFrame': '28 days after inclusion', 'description': 'The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28'}], 'secondaryOutcomes': [{'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.', 'timeFrame': '90 days after inclusion', 'description': 'Time from admission to death or last news, censored at D90'}, {'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay', 'timeFrame': '90 days after inclusion', 'description': 'The time between admission to IS and live discharge from hospital, death is considered a concurrent risk, the data are censored at 90 days'}, {'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and the number of days with recourse to invasive therapies', 'timeFrame': '90 days after inclusion', 'description': 'Number of days with mechanical ventilation, with amines, with recourse to extra-renal purification (EER) during the IS stay.'}, {'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.', 'timeFrame': '90 days after inclusion', 'description': 'Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.'}, {'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and describe changes in frailty between ICU admission and D90 in patients alive at D90.', 'timeFrame': '90 days after inclusion', 'description': 'Change in frailty score defined by the CFS (continuous) between admission and D90 (in hospital or at home).'}, {'measure': 'To study the association, independently of known risk factors, between the frailty score on admission and describe quality of life at D90 in patients alive at D90.', 'timeFrame': '90 days after inclusion', 'description': 'Quality of life measured by the EQ5D score at D90 (in hospital or at home).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between \\[6-7\\] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.\n\nIn the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.\n\nThe objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.\n\nThis analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.', 'detailedDescription': 'Recent studies show the impact of frailty in a middle-aged or even young population of patients admitted to critical care in terms of mortality (13), and the persistent risk of impairment of physical and mental capacities after resuscitation (14). To date, few studies have looked at clinical frailty as a risk factor for mortality in a middle-aged or young population, more specifically those suffering from septic shock, which is already known to be a major factor in morbidity and mortality (15,16), with repercussions on long-term quality of life.\n\nThe aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between \\[6-7\\] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.\n\nIn the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.\n\nThe objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.\n\nThis analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients admitted to intensive care will be studied for this study. Patients meeting the inclusion criteria and with no non-inclusion criteria will be included in the study after obtaining the patient's or relative's, if applicable, non-objection.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years and ≤ 65 years\n* Patient admitted to intensive care - resuscitation\n* Patient admitted for suspected or documented type 3 sepsis\n* Presence of vasopressor amines to maintain MAP \\> 65mmHg despite filling\n* Lactatemia ≥ 2 mmol/L on admission.\n\nExclusion Criteria:\n\n* Patient moribund on admission\n* Patients with severe pre-existing dementia and/or cognitive decline, suffering from severe neurodegenerative diseases that prevent the patient from living independently at baseline, including mental illness requiring institutionalisation, including acquired or congenital mental retardation, etc.\n* Pregnant women or women in labour\n* Patients under guardianship or curatorship\n* Patients deprived of their liberty\n* Patient and/or family unable to speak or understand French.'}, 'identificationModule': {'nctId': 'NCT05928767', 'acronym': 'Woodstock', 'briefTitle': 'Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Lens'}, 'officialTitle': 'Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.', 'orgStudyIdInfo': {'id': '2023-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '62408', 'city': 'Béthune', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ghada SBOUI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ch Germon Et Gauthier', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'zip': '62321', 'city': 'Boulogne-sur-Mer', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CH Boulogne sur Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre QUENOT, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre GAUDET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Guillaume DEGOUY, Dr', 'role': 'CONTACT', 'email': 'gdegouy@ch-lens.fr', 'phone': '03.21.69.12.34'}, {'name': 'MELANIE VERLAY', 'role': 'CONTACT', 'email': 'mverlay@ch-lens.fr', 'phone': '03.21.69.10.28'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Lens', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}