Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 1:34 PM
Study NCT ID:
NCT05175534
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contributions of Transesophageal Echocardiography in Liver Transplant Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-27', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine the cardiac alterations observed during reperfusion phase', 'timeFrame': 'during liver transplant', 'description': 'relationship between cardiac dysfunction and development of post reperfusion syndrome'}], 'secondaryOutcomes': [{'measure': 'determine the cardiac alterations during episodes of hemodynamic instability', 'timeFrame': 'during liver transplant', 'description': 'hemodynamic instability was defined as a decrease in the mean arterial pressure (MAP) ≥ 30% from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '38032448', 'type': 'DERIVED', 'citation': 'Gonzalez-Suarez S, Corbett M, Hernandez-Martinez A. Impact of graft reperfusion on cardiac function assessed by transesophageal echocardiography during liver transplantation: an observational retrospective study. J Clin Monit Comput. 2024 Apr;38(2):301-311. doi: 10.1007/s10877-023-01110-5. Epub 2023 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to describe the safety and impact of transesophageal echocardiography in instability episodes during liver transplantation, especially during reperfusion stage.\n\nAfter institutional review board approval, this study was performed in Vall d´Hebron University Hospital including patients undergoing liver transplantation Interventions: peroperative transesophageal echocardiography A transesophageal echocardiography scan was performed in case of hemodynamic instability episodes, and immediately after vascular unclamping.\n\nThe investigators registered percentatge of patients with diastolic/systolic dysfunction, hypovolemia, vasodilatation, embolism and percentatge of patients with postreperfusion syndrome', 'detailedDescription': 'A TEE scan was performed in case of hemodynamic instability episodes defined by a decrease of 30% of the mean arterial pressure (MAP) during at least 1 min, and in all patients during immediate graft reperfusion phase and up 30 minutes.\n\nThe instability hemodynamic state was classified into four categories: diastolic failure, systolic failure, hypovolemia and vasodilatation.\n\nThe diastolic evaluation was performed at ME 4C view using pulsed doppler of the mitral and tricuspid valve at the level of the leaflet tips and tissue Doppler motion of the mitral and tricuspid annulus. The systolic evaluation was performed using tissue Doppler motion of the mitral and tricuspid annulus evaluating S´. Hypovolemia was registered such low filling pressures (mitral lateral E/e´\\<10 m/s), cardiac index \\< 2.5 l . min-1 . m-2 and close approximation of the papillary muscles in the TG Mid SAX view. Vasodilatation was registered such low filling pressures (mitral E/e´\\< 10 m/s) and CI \\>2.5 l. min-1 . m-2).\n\nAn assessment of cardiac filling volumes and contractility, were obtained at two levels: the mid-esophageal four-chamber view (ME 4C) to evaluate the interaction of left and right ventricles and detect possible venous air embolism; and in the trans-gastric mid short axis view (TG mid SAX), to evaluate left ventricular size for the diagnosis of hypovolemia secondary to hemorrhage or altered venous return due to surgical maneuvers on the liver, and segmental wall motion. If the TG mid SAX view was not possible due to the posterior retraction of the stomach during surgery, the ME 4C view, mid-esophageal two chamber view (ME 2C) and mid-esophageal long axis view (ME LAX) was used for the diagnosis of left ventricle systolic dysfunction, and mid-esophageal bicaval view (ME bicaval) was used for the volemia evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing liver transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients undergoing liver transplantation\n\n\\-\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05175534', 'briefTitle': 'Contributions of Transesophageal Echocardiography in Liver Transplant Surgery', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Contributions of Transesophageal Echocardiography During Episodes of Hemodynamic Instability in Liver Transplant Surgery', 'orgStudyIdInfo': {'id': 'PR(AG)511/2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'monitoring', 'type': 'PROCEDURE', 'description': 'peroperative transesophageal echocardiography for monitoring in liver transplant surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Susana González Suárez', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Vall d´Hebron Research Institute VHIR', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Susana González-Suárez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vall d´Hebron University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}