Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-07 @ 12:20 PM
Study NCT ID:
NCT04890860
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right ventricular failure', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': '1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)\n2. RV fractional area change below 35%\n3. End-diastole diameter ratio between RV and left ventricle \\> 0.6\n4. Ratio between S and D wave or inverse D wave in supra-hepatic veins'}, {'measure': 'Portal flow measured by Doppler', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': 'flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic acquisition', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': 'Feasability of all measurements (RV failure with the 4 criteria:\n\n1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)\n2. RV fractional area change below 35%\n3. End-diastole diameter ratio between RV and left ventricle \\> 0.6\n4. Ratio between S and D wave or inverse D wave in supra-hepatic veins)'}, {'measure': 'Echocardiographic acquisition', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': 'Feasability of all measurements (RV failure with the portal flow with Doppler)'}, {'measure': 'Concordance of pulsatile flow assessment', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': 'Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery'}, {'measure': 'Concordance of RV dysfunction measurements', 'timeFrame': 'First 24 hours post cardiac surgery', 'description': 'Concordance of repeated measurements of :\n\n1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)\n2. RV fractional area change below 35%\n3. End-diastole diameter ratio between RV and left ventricle \\> 0.6\n4. Ratio between S and D wave or inverse D wave in supra-hepatic veins'}, {'measure': 'Preoperative RV dysfunction', 'timeFrame': '30 days before cardiac surgery', 'description': 'As defined\n\n1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s)\n2. RV fractional area change below 35%\n3. End-diastole diameter ratio between RV and left ventricle \\> 0.6\n4. Ratio between S and D wave or inverse D wave in supra-hepatic veins'}, {'measure': 'Acute kidney injury', 'timeFrame': 'one week after surgery', 'description': 'defined by KDIGO criteria as creatininemia elevation above \\> 26 micromol/L during the first 48 hours or +50% during the first week, oliguria with urine output less than 0.5 mL/kg/h during 6 hours.'}, {'measure': 'Cholestasis', 'timeFrame': 'one week after surgery', 'description': 'Conjugate bilirubin elevation above 12 mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Echocardiography', 'Right ventricular dysfunction', 'Doppler', 'Portal vein Doppler', 'Ventricular function'], 'conditions': ['Postoperative Complications', 'Heart Diseases', 'Heart Failure', 'Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '19151265', 'type': 'BACKGROUND', 'citation': 'Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.'}, {'pmid': '19151264', 'type': 'BACKGROUND', 'citation': 'Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.'}, {'pmid': '28151822', 'type': 'BACKGROUND', 'citation': 'Denault AY, Beaubien-Souligny W, Elmi-Sarabi M, Eljaiek R, El-Hamamsy I, Lamarche Y, Chronopoulos A, Lambert J, Bouchard J, Desjardins G. Clinical Significance of Portal Hypertension Diagnosed With Bedside Ultrasound After Cardiac Surgery. Anesth Analg. 2017 Apr;124(4):1109-1115. doi: 10.1213/ANE.0000000000001812.'}, {'pmid': '20620859', 'type': 'BACKGROUND', 'citation': 'Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.', 'detailedDescription': 'In cardiac surgical patients, RV dysfunction is associated with organ hypoperfusion and venous congestion leading to increased morbidity and mortality.\n\nNon-invasive methods used to assess RV function are 2D-echocardiographic measurement of tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (EF), RV fractional area change (FAC), 3D assessment of RV function, tissue Doppler assessment of velocities, and magnetic resonance imaging (MRI). Though MRI is the gold standard method to assess RV function, it cannot be used in the perioperative period.\n\nIn the present prospective observational study, The investigators investigated the association between the pattern of portal venous flow and RV function as assessed by echocardiography in the postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years old\n* Ability to provide an informed consent\n* Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Insufficient echogenicity'}, 'identificationModule': {'nctId': 'NCT04890860', 'acronym': 'DVDDP', 'briefTitle': 'Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery', 'orgStudyIdInfo': {'id': '2020/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.', 'interventionNames': ['Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass']}], 'interventions': [{'name': 'cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass', 'type': 'OTHER', 'description': 'cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass', 'armGroupLabels': ['Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'CMC Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}