Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT03865095
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2019-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Mass Loss in Critically Ill Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'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': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass loss', 'timeFrame': '7 days', 'description': 'Change in cross sectional area of rectus femoris muscle estimated by ultrasound'}], 'secondaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 days after enrolment', 'description': 'mortality 28 days after enrolment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Care', 'Muscle loss', 'Rectus femoris cross sectional area', 'Muscle ultrasound'], 'conditions': ['Muscle Loss']}, 'referencesModule': {'references': [{'pmid': '36639540', 'type': 'DERIVED', 'citation': 'Hrdy O, Vrbica K, Kovar M, Korbicka T, Stepanova R, Gal R. Incidence of muscle wasting in the critically ill: a prospective observational cohort study. Sci Rep. 2023 Jan 13;13(1):742. doi: 10.1038/s41598-023-28071-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.', 'detailedDescription': 'The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU.\n\nStudy data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation.\n\nChanges in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill adult patients admitted to intensive care unit with suspect length of artificial ventilation more than 48 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* mechanical ventilation expected for at least 48 hours\n\nExclusion Criteria:\n\n* Clinical Frailty Score above 7 prior admission\n* neuromuscular disease in previous medical history\n* amputated lower extremities\n* trauma of lower extremities involving tights\n* age under 18 years\n* inability to perform ultrasound examination\n* death or discharge prior completion of protocol\n* full verticalization prior completion of protocol'}, 'identificationModule': {'nctId': 'NCT03865095', 'acronym': 'MUSIC', 'briefTitle': 'Muscle Mass Loss in Critically Ill Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'CT0012019'}}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno and Masaryk University Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Roman Gal, M.D., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Brno and Masaryk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brno University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}