Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 11:59 AM
Study NCT ID:
NCT01971333
Status:
UNKNOWN
Last Update Posted:
2013-10-30
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Preload Parameters During Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean arterial pressure changes', 'timeFrame': 'one day'}, {'measure': 'Central venous pressure changes', 'timeFrame': 'one day'}, {'measure': 'Heart rate changes', 'timeFrame': 'one day'}], 'primaryOutcomes': [{'measure': 'Change of cardiac index after fluid loading', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'Fluid responsiveness parameters: pulse pressure variation', 'timeFrame': 'one day'}, {'measure': 'Fluid responsiveness parameters: stroke volume variation', 'timeFrame': 'one day'}, {'measure': 'Fluid responsiveness parameters: plethysmographic variation index', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulse pressure variation', 'stroke volume variation', 'plethysmographic variation index', 'fluid responsiveness'], 'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '23348202', 'type': 'BACKGROUND', 'citation': 'Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.'}, {'pmid': '27167058', 'type': 'DERIVED', 'citation': 'Wu CY, Cheng YJ, Liu YJ, Wu TT, Chien CT, Chan KC; NTUH Center of Microcirculation Medical Research (NCMMR). Predicting stroke volume and arterial pressure fluid responsiveness in liver cirrhosis patients using dynamic preload variables: A prospective study of diagnostic accuracy. Eur J Anaesthesiol. 2016 Sep;33(9):645-52. doi: 10.1097/EJA.0000000000000479.'}]}, 'descriptionModule': {'briefSummary': 'The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.', 'detailedDescription': 'Fluid management is crucial during liver transplantation. Patients with cirrhosis and portal hypertension have an altered blood volume distribution and pooling in the splanchnic circulation. Excess administration of intravenous fluid may increase portal hypertension due to splanchnic venous congestion and may also aggravate coagulopathy by dilution. On the other hand, fluid restriction may risk systemic and especially renal hypoperfusion. Traditional static fluid parameter, such as central venous pressure, pulmonary artery occlusion pressure, have been reported inaccurate to predict fluid responsiveness. In comparison, the recent developed dynamic fluid parameters based on heart-lung interaction were reported to be good preload indicators in a variety of different surgical settings. However, the validity of such dynamic fluid parameters is highly dependent on The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital\n\nExclusion Criteria:\n\n* Allergic reaction\n* preexisting arrythmia'}, 'identificationModule': {'nctId': 'NCT01971333', 'briefTitle': 'Dynamic Preload Parameters During Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Validity of Dynamic Preload Parameters During Liver Transplantation', 'orgStudyIdInfo': {'id': '201309024RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplantation', 'description': 'Compare intraoperative change of dynamic parameters after fluid loading:\n\n1. pulse pressure variation\n2. stroke volume variation\n3. plethysmographic variation index'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun Yu Wu, M.D.', 'role': 'CONTACT', 'email': 'longersolo@gmail.com', 'phone': '+886-2-23123456', 'phoneExt': '62158'}, {'name': 'Chun Yu Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology, NTUH, Taipei, Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chun Yu Wu, M.D.', 'role': 'CONTACT', 'email': 'longersolo@gmail.com', 'phone': '+886-2-23123456', 'phoneExt': '62158'}], 'overallOfficials': [{'name': 'Chun Yu Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}