Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT07303335
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-11', 'size': 358027, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-27T05:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sarcopenia at the time of ICU admission.', 'timeFrame': 'Baseline at admission to ICU', 'description': 'Describe the prevalence of sarcopenia at the time of ICU admission in patients with an expected duration of mechanical ventilation (MV) exceeding 48 hours.'}], 'secondaryOutcomes': [{'measure': 'Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning', 'timeFrame': 'From ICU admission to 30 days follow-up', 'description': 'Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning, defined as failure of definitive disconnection from mechanical ventilation'}, {'measure': 'Detecting the appearance of other complications', 'timeFrame': 'From admission to 30 days follow up', 'description': 'Detecting the appearance of other complications during admission such as: the appearance of refeeding syndrome or increased prevalence of insulin resistance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia', 'Critical Illness', 'Intensive Care (ICU) Myopathy', 'Body Composition Measurement', 'Bio-Impedance Measurements', 'Ultrasound Evaluation']}, 'referencesModule': {'references': [{'pmid': '39549651', 'type': 'BACKGROUND', 'citation': 'Sostakaite G, Jauniskyte M, Budrys D, Budrevicius K, Salciute-Simene E, Svetikiene M, Jovaisa T, Zvirblis T, Klimasauskas A, Sipylaite J. Comparison of Two Techniques to Assess Muscle Mass Loss During ICU Stay: Muscle Ultrasound vs Bioelectrical Impedance Analysis. Nutrition. 2025 Feb;130:112607. doi: 10.1016/j.nut.2024.112607. Epub 2024 Oct 24.'}, {'pmid': '31890223', 'type': 'BACKGROUND', 'citation': 'Nakanishi N, Tsutsumi R, Okayama Y, Takashima T, Ueno Y, Itagaki T, Tsutsumi Y, Sakaue H, Oto J. Monitoring of muscle mass in critically ill patients: comparison of ultrasound and two bioelectrical impedance analysis devices. J Intensive Care. 2019 Dec 16;7:61. doi: 10.1186/s40560-019-0416-y. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational study at the ICU of Hospital Mútua de Terrassa, running from May to December 2025. The primary goal is to determine the prevalence of sarcopenia in adult patients requiring more than 48 hours of mechanical ventilation. Sarcopenia is assessed using the SARC-F score, impedanciometry, and quadriceps ultrasound. Secondary aims include tracking the development of ICU-Acquired Weakness (ICU-AW) using the MRC score. All data is collected anonymously after obtaining informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to a polyvalent (medical and surgical) ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years old.\n* Expected duration of mechanical ventilation (MV) exceeding 48 hours.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Mechanical ventilation not exceeding 48 hours.\n* Do-not-resuscitate (DNR) orders or limitations of therapeutic effort upon admission.'}, 'identificationModule': {'nctId': 'NCT07303335', 'acronym': 'SARC-ICU', 'briefTitle': 'Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Mutua de Terrassa'}, 'officialTitle': 'Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.', 'orgStudyIdInfo': {'id': 'P/25-054/Fundació assistencial'}, 'secondaryIdInfos': [{'id': 'Mutua Terrassa', 'type': 'OTHER', 'domain': 'Fundació Assistencial Mutua Terrassa'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill adults (medical or surgical) expected to require prolonged mechanical ventilation.', 'description': 'Assesment of the body composition using Rectus Femoris (RF) Ultrasound and Bioelectrical Impedance Analysis (BIA)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08012', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'All collected IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Mutua de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}