Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-28 @ 9:53 PM
Study NCT ID:
NCT03371602
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of atrophy of the myofibers of the human diaphragm', 'timeFrame': 'day 0 (day of the surgery)', 'description': 'Atrophy of the myofibers will be assessed by comparison of the cross sectional area of the three different types of myofibers between the sepsis-mechanical ventilation group and the sepsis group, the ventilation group and the control group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiration, Artificial']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling;\n* Affiliated to a social security or similar system;\n* Not subject to legal protection;\n* Having given consent to participate in the study (or consent from the trusted person)\n* Control group (C): non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy\n* Sepsis group (S): Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)\n* Group Mechanical Ventilation (MV): Patient in brain death for which a multi organ sample is planned\n* Mechanical Ventilation + Sepsis (S-MV) group: Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)\n\nExclusion Criteria:\n\n* Pregnant woman (diagnosis of interrogation)\n* severe and / or unbalanced chronic respiratory disease; severe malnutrition\n* Long-term corticosteroids\\> 5mg / day for more than 1 month\n* Myopathy\n* surgery by laparoscopic\n\nBy group:\n\n* Control group: Sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability\n* Mechanical Ventilation Group: Sepsis, duration of controlled mechanical ventilation \\<24 hours or\\> 7 days\n* Sepsis Group: Preoperatively controlled mechanical ventilation\n* Mechanical Ventilation - Sepsis Group: duration of controlled mechanical ventilation \\<24 hours or\\> 7 days'}, 'identificationModule': {'nctId': 'NCT03371602', 'acronym': 'SEPTIC', 'briefTitle': 'Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm', 'orgStudyIdInfo': {'id': '69HCL15_0423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy', 'interventionNames': ['Procedure: surgery']}, {'type': 'EXPERIMENTAL', 'label': 'sepsis group', 'description': 'Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)', 'interventionNames': ['Procedure: surgery']}, {'type': 'EXPERIMENTAL', 'label': 'mechanical ventilation group', 'description': 'Patient in brain death for whom a multi-organ sampling is planned', 'interventionNames': ['Procedure: multi-organ sampling']}, {'type': 'EXPERIMENTAL', 'label': 'mechanical ventilation - sepsis group', 'description': 'Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.', 'armGroupLabels': ['control group', 'mechanical ventilation - sepsis group', 'sepsis group']}, {'name': 'multi-organ sampling', 'type': 'PROCEDURE', 'description': 'a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.', 'armGroupLabels': ['mechanical ventilation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Céline Guichon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}