Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06899867
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013815', 'term': 'Thermodilution'}], 'ancestors': [{'id': 'D007201', 'term': 'Indicator Dilution Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac index variation measured by thermodilution compared with transesophageal echography', 'timeFrame': 'At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery.\n\nThis study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'age \\> 18 years old, undergoing liver transplantation at Croix-Rousse hospital, HCL, Lyon', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver transplantation\n* adults\n\nExclusion Criteria:\n\n* \\- Oesophageal varice ligation \\< 14 days\n* Mediastinal radiotherapy\n* Femoral bypass\n* Severe lower extremity artery disease'}, 'identificationModule': {'nctId': 'NCT06899867', 'briefTitle': 'Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Is Cardiac Index, Assessed by Transpulmonary Thermodilution, Reliable During Liver Transplantation Compared to Transesophageal Echocardiography : a Monocentric Cohort', 'orgStudyIdInfo': {'id': '24-5431'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.', 'description': '* Monitoring transesophageal echography, transpulmonary thermodilution\n* Measuring cardiac index, preload dependence (end-expiratory test) at 4 steps of surgery\n* Surgical anastomosis echography\n* Demographic data, biological data, post operation data', 'interventionNames': ['Other: Measure of cardiac index with thermodilution and transesophageal echocardiography', 'Other: Surgical anastomosis echography']}], 'interventions': [{'name': 'Measure of cardiac index with thermodilution and transesophageal echocardiography', 'type': 'OTHER', 'description': 'At 4 times of surgery, end-expiratory occlusion (EEO) test and measure of cardiac index before and after test with ETO and thermodilution', 'armGroupLabels': ['Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.']}, {'name': 'Surgical anastomosis echography', 'type': 'OTHER', 'description': 'Visualisation of surgical anastomosis through transesophageal echocardiography : stenosis, doppler velocity, collar diameter', 'armGroupLabels': ['Patients undergoing liver transplantation at Croix-Rousse University Hospital, HCL, Lyon.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'France', 'state': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BLET Alice, MD,PhD', 'role': 'CONTACT', 'email': 'alice.blet@chu-lyon.fr', 'phone': '371239'}], 'facility': 'Croix Rousse Hsopital', 'geoPoint': {'lat': 45.60366, 'lon': -0.84802}}], 'centralContacts': [{'name': 'Pr Alice Blet', 'role': 'CONTACT', 'email': 'alice.blet@chu-lyon.fr', 'phone': '371239'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}