Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT03917667
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sarcopenia at hospital admission', 'timeFrame': '72 hours', 'description': 'Prevalence of sarcopenia at hospital admission. A prevalent case of sarcopenia will be considered if a patient fulfills the EWGSOP2 at admission'}, {'measure': 'Incidence of sarcopenia between admission and discharge', 'timeFrame': 'Up to 20 days', 'description': 'A incident case of sarcopenia will be considered if a patient that do not fulfill EWGSOP2 diagnostic criteria at admission, fulfills the diagnostic criteria at discharge (diagnosis will be considered as a dichotomous variable -yes/no-).'}, {'measure': 'Occurence of risk factors', 'timeFrame': 'Up to 20 days', 'description': 'Presence of at least one risk factor involved in the development of sarcopenia during hospitalization. Risk factors defined as: bed immobilization, denutrition, loss of autonomy, cognitive troubles, depression, mobility loss.'}, {'measure': 'Occurence of adverse events', 'timeFrame': 'Up to 20 days', 'description': 'Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.'}, {'measure': 'Occurence of adverse events', 'timeFrame': '3 months after hospital discharge', 'description': 'Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.'}, {'measure': 'Occurence of adverse events', 'timeFrame': '1 year after hospital discharge', 'description': 'Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': "Sarcopenia is a disease characterized by progressive and generalized loss of skeletal muscle mass and strength, and is related to worse clinical outcomes, physical impairment, and mortality in all healthcare settings. This nutrition-related syndrome is a reversible condition, and can be effectively counteracted by exercise and nutritional support.\n\nThe prevalence of sarcopenia varies widely depending on the criteria, methods, and cut-off points used for its assessment. Although the European Working Group on Sarcopenia in Older People (EWGSOP) recommended assessing sarcopenia in geriatric patients in all care settings, few studies addressing hospitalized older patients have been carried out, mainly due to the characteristics of acute healthcare settings and their in-patients and because the criteria used are difficult to carry out there. Therefore, this condition remains under-recognized in the setting where this disease is likely to be more present.\n\nSarcopenia is expected to be a major healthcare problem in the upcoming years in Europe so, in response to this claim for Public Health Action, the European Union Geriatric Medicine Society founded the Special Interest Group (SIG) on sarcopenia that has taken the lead of bridging the gaps between clinical and research in sarcopenia field, in line with the Conference on Frailty and Sarcopenia Research Task Force, and the World Health Organization's strategies to promote Optimal Aging. This goal of SIG on sarcopenia by EuGMS is being carried out by promotion of collaboration among International scientific societies and institutions; they have recently launched the Revised European consensus on definition and diagnosis (EWGSOP2), the SARCUS project on ultrasound for sarcopenia assessment in European countries, and the first International Registry of patients with sarcopenia.\n\nThis study aims to provide an overview of sarcopenia assessment older patients hospitalized in acute-care geriatric units.\n\nThis is a longitudinal, prospective, observational study in consecutive hospitalized patients in the CHU Brugmann Hospital.\n\nThis study has 5 objectives :\n\n1. To determine prevalence of sarcopenia among hospitalized patients in CHU Brugmann.\n2. To determine incidence of sarcopenia during the hospital stay.\n3. To identify risk factors for the development of sarcopenia at the time of admission and during hospitalization.\n4. To assess sarcopenia as a risk factor for clinical adverse outcomes during hospitalization (hospital-acquired infections, falls, delirium, longer length-of-stay, disability, and mortality).\n5. To assess sarcopenia as a risk factor for clinical adverse outcomes post-discharge (institutionalization, hospitalizations, falls, disability, and mortality) at 3- and 12-month follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 70 years and older who are admitted to the acute care geriatric units of the CHU Brugmann Hospital. This may include acute medical conditions or chronic disease decompensation; patients are eligible for referral to acute geriatric units due to medical diseases, such as urinary tract infections, respiratory tract infections, pneumonia, coronary heart diseases, atrial fibrillation, congestive heart failure, stroke, delirium, electrolyte disturbances, kidney disease, cancer, etc...', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients aged 70 years and older who are admitted to the acute care geriatric units of the CHU Brugmann Hospital.\n\nExclusion Criteria:\n\n* Hip or lower limbs fractures, amputations,\n* Terminally ill patients admitted for palliative care,\n* Neurological patients with hemiplegia or stroke limiting the walking evaluation'}, 'identificationModule': {'nctId': 'NCT03917667', 'briefTitle': 'Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+', 'orgStudyIdInfo': {'id': 'CHUB-Sarcopenia 9+'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Geriatric patients', 'description': 'Patients aged 70 years and older who are admitted to the acute care geriatric units.', 'interventionNames': ['Diagnostic Test: EWGSOP2']}], 'interventions': [{'name': 'EWGSOP2', 'type': 'DIAGNOSTIC_TEST', 'description': 'EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia, considered as a dichotomous variable -yes/no- in presence of low grip strength + low muscle mass + low gait speed.', 'armGroupLabels': ['Geriatric patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Murielle Surquin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Murielle Surquin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Geriatry Department', 'investigatorFullName': 'Murielle Surquin', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}