Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-20 @ 10:36 PM
Study NCT ID:
NCT05594550
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2022-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of muscle area at T7 level indexed in cm²/m².', 'timeFrame': 'At hospital admission', 'description': 'use of CT measurements to discriminate between the 2 groups (deceased versus alive)'}], 'secondaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': 'within the 28 days'}, {'measure': 'Ventilator free days', 'timeFrame': 'within the 28 days'}, {'measure': 'number of days in Intensive care unit', 'timeFrame': 'within the 28 days'}, {'measure': 'number of days in hospital', 'timeFrame': 'within the 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrom (SARS-Cov 2)']}, 'descriptionModule': {'briefSummary': 'Sarcopenia is a risk factor for adverse outcome in critically ill patients. Sarcopenia might be estimated from muscle surface measure on tomodensitometry.\n\nThe purpose of the study is to identify if muscle surfaces measured on thoracic tomodensitometry are associated with mortality in patients with acute respiratory distress syndrome due to SARS-Cov-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with acute respiratory syndrome due to SARS-Cov-2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients hospitalized in intensive care for SARS-Cov-2 infection since january 2020\n* Thoracic TDM within the 30 day preceding ICU admission and up to 24 hours after ICU admission\n\nExclusion Criteria:\n\n* Pregnancy\n* Neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT05594550', 'acronym': 'MUSCOV', 'briefTitle': 'Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection', 'orgStudyIdInfo': {'id': 'NGUYEN 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': '28-day survival', 'description': 'Alive 28 days after intensive care admission', 'interventionNames': ['Other: Data collection', 'Other: analysis of thoracic scans']}, {'label': '28-day death', 'description': 'Deceased 28 days after intensive care admission', 'interventionNames': ['Other: Data collection', 'Other: analysis of thoracic scans']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Demographic data:\n\nAge, Sex, weight, height, main history and treatments.\n\n\\- Biological data: CRP, PCT, albumin, pre-albumin', 'armGroupLabels': ['28-day death', '28-day survival']}, {'name': 'analysis of thoracic scans', 'type': 'OTHER', 'description': 'muscle area calculated on the T7 and T12 thoracic slices', 'armGroupLabels': ['28-day death', '28-day survival']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maxime NGUYEN', 'role': 'CONTACT', 'email': 'maxime.nguyen-soenen@chu-dijon.fr', 'phone': '380293528', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}