Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT02306018
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2014-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-07', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-11-29', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac output', 'timeFrame': 'intraoperative', 'description': 'L/minute, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution'}], 'secondaryOutcomes': [{'measure': 'systemic vascular resistance', 'timeFrame': 'intraoperative', 'description': 'dyne s/cm5,28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution'}, {'measure': 'stroke volume variability', 'timeFrame': 'during surgery every 10 minute, event time for example, anhepatic, liver in, reperfusion, using inotropics, changing ventilator setting', 'description': '%, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution'}, {'measure': 'stroke volume', 'timeFrame': 'intraoperative', 'description': 'ml, 28 participants, EV1000 by femiral artery, Pulmonary artery thermodilution'}, {'measure': 'ejection fraction', 'timeFrame': 'intraoperative', 'description': '%, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver transplantation', 'cardiac output'], 'conditions': ['Liver Disease']}, 'referencesModule': {'references': [{'pmid': '22858882', 'type': 'RESULT', 'citation': 'Feltracco P, Biancofiore G, Ori C, Saner FH, Della Rocca G. Limits and pitfalls of haemodynamic monitoring systems in liver transplantation surgery. Minerva Anestesiol. 2012 Dec;78(12):1372-84. Epub 2012 Aug 3.'}, {'pmid': '23492964', 'type': 'RESULT', 'citation': 'Uemura K, Kawada T, Inagaki M, Sugimachi M. A minimally invasive monitoring system of cardiac output using aortic flow velocity and peripheral arterial pressure profile. Anesth Analg. 2013 May;116(5):1006-1017. doi: 10.1213/ANE.0b013e31828a75bd. Epub 2013 Mar 14.'}, {'pmid': '19059920', 'type': 'RESULT', 'citation': 'Biancofiore G, Critchley LA, Lee A, Bindi L, Bisa M, Esposito M, Meacci L, Mozzo R, DeSimone P, Urbani L, Filipponi F. Evaluation of an uncalibrated arterial pulse contour cardiac output monitoring system in cirrhotic patients undergoing liver surgery. Br J Anaesth. 2009 Jan;102(1):47-54. doi: 10.1093/bja/aen343.'}, {'pmid': '21680855', 'type': 'RESULT', 'citation': 'Biancofiore G, Critchley LA, Lee A, Yang XX, Bindi LM, Esposito M, Bisa M, Meacci L, Mozzo R, Filipponi F. Evaluation of a new software version of the FloTrac/Vigileo (version 3.02) and a comparison with previous data in cirrhotic patients undergoing liver transplant surgery. Anesth Analg. 2011 Sep;113(3):515-22. doi: 10.1213/ANE.0b013e31822401b2. Epub 2011 Jun 16.'}, {'pmid': '22410036', 'type': 'RESULT', 'citation': 'Tsai YF, Su BC, Lin CC, Liu FC, Lee WC, Yu HP. Cardiac output derived from arterial pressure waveform analysis: validation of the third-generation software in patients undergoing orthotopic liver transplantation. Transplant Proc. 2012 Mar;44(2):433-7. doi: 10.1016/j.transproceed.2011.12.045.'}, {'pmid': '19281442', 'type': 'RESULT', 'citation': 'Galluccio ST, Chapman MJ, Finnis ME. Femoral-radial arterial pressure gradients in critically ill patients. Crit Care Resusc. 2009 Mar;11(1):34-8.'}, {'pmid': '16029225', 'type': 'RESULT', 'citation': 'Arnal D, Garutti I, Perez-Pena J, Olmedilla L, Tzenkov IG. Radial to femoral arterial blood pressure differences during liver transplantation. Anaesthesia. 2005 Aug;60(8):766-71. doi: 10.1111/j.1365-2044.2005.04257.x.'}, {'pmid': '20005373', 'type': 'RESULT', 'citation': 'Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Hwang GS. Comparison of stroke volume variations derived from radial and femoral arterial pressure waveforms during liver transplantation. Transplant Proc. 2009 Dec;41(10):4220-8. doi: 10.1016/j.transproceed.2009.09.050.'}, {'pmid': '17611251', 'type': 'RESULT', 'citation': 'Sakka SG, Kozieras J, Thuemer O, van Hout N. Measurement of cardiac output: a comparison between transpulmonary thermodilution and uncalibrated pulse contour analysis. Br J Anaesth. 2007 Sep;99(3):337-42. doi: 10.1093/bja/aem177. Epub 2007 Jul 4.'}, {'pmid': '23625132', 'type': 'RESULT', 'citation': 'Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26.'}, {'pmid': '22647561', 'type': 'RESULT', 'citation': 'Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366.'}, {'pmid': '21092252', 'type': 'RESULT', 'citation': 'Bendjelid K, Giraud R, Siegenthaler N, Michard F. Validation of a new transpulmonary thermodilution system to assess global end-diastolic volume and extravascular lung water. Crit Care. 2010;14(6):R209. doi: 10.1186/cc9332. Epub 2010 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.', 'detailedDescription': 'In cirrhotic patient undergoing liver transplantation, there are an altered patterm of circulation, which is characterized by increased cardiac output, decreased peripheral vascular resistance, and reduced ventricular response to physiological, pharmacological, and surgical stress. Large blood loss and clamping/declamping of the inferior vena cava and portal vein during liver transplantation surgery can affect intravascular volume status, which in turn can lead to hemodynamic instability. Therefore, reliable cardiac output monitoring is particularly useful in the cirrhotic patient undergoing liver transplant. Pulmonary artery thermodilution has been used as a standard method for cardiac output assessment for many years. Pulmonary artery catheter can cause rare but serious complications. And it has some limitations for continuously monitoring cardiac output during rapid hemodynamic changes.\n\nRecently, several minimally invasive CO monitors have been developed. The pulse contour technique continuously estimates CO through mathematical analysis of the waveform of arterial pressure. However, previous studies evaluating the reliability of the pulse contour techniques indicated conflicting results in cirrhotic patients during liver transplantation. Most of studies were performed by analyzing from radial artery pressure waveform. Because of rapid changing of intravascular volume, using inotropics, the monitoring of femoral artery pressure has been recommended during liver transplantation.\n\nA new pulse wave analysis system has developed and introduced into clinical practice that consists of a specific thermistor -tipped femoral arterial catheter ( the VolumeView™ catheter) and the EV1000™ monitoring platform ( Edward lifesciences, Irvine, CA, USA). To continuously assess CO based on the femoral arterial pressure curve signal and it uses transpulmonary thermodilution for calibration. We are trying to evaluate the agreement of cardiac output measurements taken using EV1000™ / VolumeView™ with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who are performed liver transplantation in Samsung medical center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsubjects undergoing living donor liver transplantation during the study period subjects older than 20yrs who can give informed consent\n\nExclusion Criteria:\n\nthose who are confirmed moderate severe aortic regurgitation by echocardiography those with infection on cannulation site'}, 'identificationModule': {'nctId': 'NCT02306018', 'briefTitle': 'Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation', 'orgStudyIdInfo': {'id': '2014-08-080-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EV1000™/volumeView™', 'interventionNames': ['Device: EV1000™/volumeView™']}], 'interventions': [{'name': 'EV1000™/volumeView™', 'type': 'DEVICE', 'armGroupLabels': ['EV1000™/volumeView™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Mi Hye Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Gwak Mi Sook', 'investigatorAffiliation': 'Samsung Medical Center'}}}}