Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
Study NCT ID:
NCT06582368
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-08-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determinants of Portal Vein Pulsatility Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid Intolerance', 'timeFrame': 'Within the first six hours of admission to the intensive care unit (simultaneously with other measures).', 'description': 'A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin.'}], 'secondaryOutcomes': [{'measure': 'Volemia', 'timeFrame': 'Within the first six hours of admission to the intensive care unit (simultaneously with other measures).', 'description': 'Volemia will be assessed using the mean systemic filling pressure analogue (MSFPa) proposed by Parkin and Leaning (2008), which estimates the overall volume status and preload of the circulatory system. This measurement provides an indirect evaluation of volemia, reflecting the balance between blood volume and vascular capacity. Higher or lower values can indicate fluid overload or deficit, respectively.'}, {'measure': 'Right Ventricular Dysfunction', 'timeFrame': 'Within the first six hours of admission to the intensive care unit (simultaneously with other measures).', 'description': 'Right ventricular dysfunction will be assessed using three ancillary measures: Tricuspid Annular Plane Systolic Excursion (TAPSE), Right Ventricular Fractional Area Change (RVFAC), and the Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area ratio (RVEDA/LVEDA). TAPSE measures longitudinal shortening of the right ventricle, RVFAC assesses overall systolic function by evaluating the change in the right ventricular area during the cardiac cycle, and RVEDA/LVEDA compares the size of the right ventricle to the left, indicating potential dilation or pressure overload.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congestion', 'portal vein pulsatility', 'fluid therapy', 'right ventricular failure', 'volemia'], 'conditions': ['Fluid Overload', 'Congestion']}, 'referencesModule': {'references': [{'pmid': '19002596', 'type': 'BACKGROUND', 'citation': 'Parkin WG, Leaning MS. Therapeutic control of the circulation. J Clin Monit Comput. 2008 Dec;22(6):391-400. doi: 10.1007/s10877-008-9147-7. Epub 2008 Nov 12.'}, {'pmid': '37742087', 'type': 'BACKGROUND', 'citation': 'Utrilla-Alvarez JD, Gopar-Nieto R, Garcia-Cruz E, Lazcano-Diaz E, Jimenez-Rodriguez GM, Rojas-Velasco G, Manzur-Sandoval D. Assessing the venous system: Correlation of mean systemic filling pressure with the venous excess ultrasound grading system in cardiac surgery. Echocardiography. 2023 Nov;40(11):1216-1226. doi: 10.1111/echo.15697. Epub 2023 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'The pulsatile pattern of the portal vein is considered a marker of right ventricular dysfunction, but volemia may also contribute to this phenomenon. The separate influence of each factor remains debated, as the interplay between right ventricular dysfunction and volume status is complex. Additionally, right ventricular dysfunction can originate from either diastolic or systolic dysfunction, further complicating the understanding of their distinct impacts on portal vein pulsatility.', 'detailedDescription': 'The pulsatile pattern of the portal vein has been recognized as a potential marker of right ventricular dysfunction, reflecting altered hemodynamics in the venous system. However, the role of volemia, or the volume status of a patient, might also significantly influence this pulsatility, complicating the interpretation of portal vein flow patterns. The distinct and combined effects of right ventricular dysfunction and volemia on portal vein pulsatility are still subjects of ongoing debate. Right ventricular dysfunction itself can arise from multiple mechanisms, including primary diastolic dysfunction, where the ventricle has impaired filling and relaxation, or systolic dysfunction, characterized by reduced contractility and ejection capacity. Understanding whether diastolic or systolic dysfunction plays a predominant role in altering portal vein pulsatility is crucial, as these nuances have important implications for accurately identifying the determinants of portal vein pulsatility index and tailoring appropriate clinical interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent.\n* Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.\n* Sinus rhythm.\n\nExclusion Criteria:\n\n* A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).\n* Any mechanical circulatory support.\n* Cardiac transplant.\n* Poor transthoracic echocardiographic window.'}, 'identificationModule': {'nctId': 'NCT06582368', 'briefTitle': 'Determinants of Portal Vein Pulsatility Index', 'organization': {'class': 'OTHER', 'fullName': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu'}, 'officialTitle': 'Determinants of Portal Vein Pulsatility Index: An Observational Study', 'orgStudyIdInfo': {'id': '9593/04.04.2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgery Patients', 'description': 'Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': '"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Serban-Ion Bubenek-Turconi, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': '"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Balan Ion Cosmin', 'investigatorAffiliation': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu'}}}}