Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT02818218
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HANY3@ccf.org', 'phone': '216-444-2250', 'title': 'YanYan Han', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Central Venous Pressure (CVP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '275', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'Central Venous Pressure (CVP) reflects the amount of blood returning to the heart (venous return) and the ability of the heart to pump the blood into the arterial system. It was captured electronically via an automated record-keeping system. 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A high CVP (\\> 8 mmHg) may indicate fluid overload, right heart failure, pulmonary hypertension, or cardiac tamponade.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'PRIMARY', 'title': 'Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.944', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.0005', 'ciLowerLimit': '-0.161', 'ciUpperLimit': '0.170', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)\\*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.\n\nThe interpretation of the SVC Collapsibility Index is categorized as follows: \\< 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and \\> 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'PRIMARY', 'title': 'Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.27', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.42', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'PRIMARY', 'title': 'Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.34', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.48', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements', 'populationDescription': 'maximum Superior Vena Cava (SVC)'}, {'type': 'SECONDARY', 'title': 'Cardiac Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': "The Cardiac Index measures the efficiency of the heart's pumping function (normal range: 2.6 to 4.2 L/min/m2). It was captured electronically via an automated record-keeping system. Cardiac Index was recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.", 'unitOfMeasure': 'L/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'SECONDARY', 'title': 'Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.298', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.07', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.24', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)\\*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.\n\nThe interpretation of the SVC Collapsibility Index is categorized as follows: \\< 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and \\> 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'SECONDARY', 'title': 'Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.22', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.37', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}, {'type': 'SECONDARY', 'title': 'Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Measurements', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.3', 'paramValue': '0.33', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.47', 'estimateComment': 'The repeated measures correlation coefficient (r\\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa', 'statisticalMethod': 'Repeated measures correlation (rmcorr)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Measurements', 'denomUnitsSelected': 'Measurements'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Liver Transplantation Patients', 'description': 'We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA (American Society of Anesthesiologists) physical status', 'classes': [{'title': '3 (Severe systemic illness)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '4 (Life-threatening systemic illness)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': '5 (Not expected to survive without the operation)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcoholic Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Billary Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatocellular Carcinoma', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Sclerosing Cholangitis', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-alcoholic Steatohepatosis (NASH)', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Viral Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-20', 'size': 134281, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-06T09:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2016-04-11', 'resultsFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-06', 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Venous Pressure (CVP)', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'Central Venous Pressure (CVP) reflects the amount of blood returning to the heart (venous return) and the ability of the heart to pump the blood into the arterial system. It was captured electronically via an automated record-keeping system. CVP were recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.\n\nLow CVP (\\< 2 mmHg) suggests hypovolemia, dehydration, or blood loss, while normal CVP (2-8 mmHg) indicates balanced fluid status. A high CVP (\\> 8 mmHg) may indicate fluid overload, right heart failure, pulmonary hypertension, or cardiac tamponade.'}, {'measure': 'Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)\\*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.\n\nThe interpretation of the SVC Collapsibility Index is categorized as follows: \\< 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and \\> 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.'}, {'measure': 'Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.'}, {'measure': 'Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Index', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': "The Cardiac Index measures the efficiency of the heart's pumping function (normal range: 2.6 to 4.2 L/min/m2). It was captured electronically via an automated record-keeping system. Cardiac Index was recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall."}, {'measure': 'Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)\\*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.\n\nThe interpretation of the SVC Collapsibility Index is categorized as follows: \\< 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and \\> 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.'}, {'measure': 'Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.'}, {'measure': 'Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)', 'timeFrame': 'From the time patients enter the operating room to leaving the operating room, up to 24 hours.', 'description': 'The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Failure']}, 'descriptionModule': {'briefSummary': 'Consecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP will be recorded.', 'detailedDescription': 'Central venous pressure (CVP) measured invasively through a central venous catheter in the internal jugular vein or through a right atrial port of a pulmonary artery catheter is commonly used during liver transplant surgery. CVP measurements at the SVC-RA junction are a function of circulating blood volume, right ventricle function, intrathoracic pressure. CVP measurements can also be affected by the presence of tricuspid regurgitation. Because central venous pressure measurements are determined by several factors and do not predict the response to subsequent fluid bolus administration, they are considered "static measures" and are poor indicators of fluid responsiveness.\n\nGiven the entirely intrathoracic location of the superior vena cava (SVC), its diameter and collapsibility with positive pressure ventilation it is a potentially attractive method of non-invasively estimating CVP.\n\nSVC diameter and collapsibility index, dynamic measures of fluid responsiveness have been successfully utilized as echocardiographic indices for fluid responsiveness in ventilated septic patients. Whether SVC collapsibility is correlated with CVP measurements in liver transplant patients is not known.\n\nConsecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing liver transplantation surgery (cadaveric and living related)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* undergoing liver transplantation surgery (cadaveric and living related)\n\nExclusion Criteria:\n\n* Contraindication to Transesophageal echocardiography'}, 'identificationModule': {'nctId': 'NCT02818218', 'briefTitle': 'Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Superior Vena Cava (SVC) Diameter and Collapsibility Index and Its Relationship to Central Venous Pressure (CVP) Measurements in Patients Undergoing Liver Transplantation', 'orgStudyIdInfo': {'id': '16-307'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liver Transplant', 'type': 'PROCEDURE', 'description': 'liver transplant recipient surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel Sessler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Outcomes Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}