Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-27 @ 4:36 PM
Study NCT ID:
NCT03197792
Status:
UNKNOWN
Last Update Posted:
2019-04-24
First Post:
2017-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006940', 'term': 'Hyperemia'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with chronic post-embolic pulmonary hypertension eligible to pulmonary endarterectomy surgery will be evaluated for venous congestion and right ventricular failure after weaning of cardiopulmonary bypass, and followed until the 7th postoperative day for the development of postoperative organ dysfunction and/or death.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-05-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2017-05-21', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent organ dysfunction plus death (POD + death) 7 days after surgery', 'timeFrame': 'On the morning of the 7th postoperative day', 'description': 'POD + death, defined as death or one of the following criterias (yes or no) present on the 7th postoperative day : (1) mechanical ventilation (excluding non-invasive ventilation) without breaks for more than 48 hours, (2) ongoing need for vasopressor therapy more than 2 hours per day (dopamine more than 5 mcg/kg/min, phenylephrine more than 50 mcg/min, norepinephrine, epinephrine, vasopressin), (3) ongoing need for mechanical circulatory support such as ECMO or IABP, and (4) continuous renal replacement therapy or new intermittent hemodialysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transesophageal ultrasound', 'TEE', 'Portal vein pulsatility', 'Splenic vein pulsatility', 'Venous congestion', 'Strain', 'Right ventricular dysfunction', 'Pulmonary hypertension', 'Venous hypertension'], 'conditions': ['Pulmonary Hypertension', 'Thromboembolism, Pulmonary', 'Perioperative/Postoperative Complications', 'Venous Hypertension', 'Cardiac Failure']}, 'referencesModule': {'references': [{'pmid': '24356157', 'type': 'BACKGROUND', 'citation': 'Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH; American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. Anesth Analg. 2014 Jan;118(1):21-68. doi: 10.1213/ANE.0000000000000016. No abstract available.'}, {'pmid': '26028638', 'type': 'BACKGROUND', 'citation': 'Jenkins D. Pulmonary endarterectomy: the potentially curative treatment for patients with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015 Jun;24(136):263-71. doi: 10.1183/16000617.00000815.'}, {'pmid': '2791245', 'type': 'BACKGROUND', 'citation': 'Dittrich HC, Chow LC, Nicod PH. Early improvement in left ventricular diastolic function after relief of chronic right ventricular pressure overload. Circulation. 1989 Oct;80(4):823-30. doi: 10.1161/01.cir.80.4.823.'}, {'pmid': '20875129', 'type': 'BACKGROUND', 'citation': 'Olson N, Brown JP, Kahn AM, Auger WR, Madani MM, Waltman TJ, Blanchard DG. Left ventricular strain and strain rate by 2D speckle tracking in chronic thromboembolic pulmonary hypertension before and after pulmonary thromboendarterectomy. Cardiovasc Ultrasound. 2010 Sep 27;8:43. doi: 10.1186/1476-7120-8-43.'}, {'pmid': '25327878', 'type': 'BACKGROUND', 'citation': 'Marston N, Brown JP, Olson N, Auger WR, Madani MM, Wong D, Raisinghani AB, DeMaria AN, Blanchard DG. Right ventricular strain before and after pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension. Echocardiography. 2015 Jul;32(7):1115-21. doi: 10.1111/echo.12812. Epub 2014 Oct 18.'}]}, 'descriptionModule': {'briefSummary': "The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.", 'detailedDescription': "While transesophageal echocardiography is recommended in patients with known or suspected cardiovascular pathology which may impact outcomes, no study has evaluated it's perioperative use in pulmonary endarterectomy surgery.\n\nMost pulmonary endarterectomy patients suffer from severe pulmonary hypertension, right heart dysfunction and central venous hypertension. Postoperative complications are closely related to the importance of residual postoperative pulmonary hypertension and right ventricular dysfunction. A portal vein pulsatility fraction of 50% or more in the perioperative setting might indicate right ventricular dysfunction and/or hypervolemia-related severe venous congestion, which may be responsible for multiple organ dysfunction and significant morbidity or mortality in critically ill patients.\n\nThe investigators believe pulmonary endarterectomy patients with a high portal vein pulsatility fraction immediately after weaning from cardiopulmonary bypass have a greater risk of developing postoperative persistent organ dysfunction and/or death. In this prospective descriptive study, the investigators will evaluate portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death 7 days after pulmonary endarterectomy.\n\nLeft and right global longitudinal strain after weaning from cardiopulmonary bypass will also be evaluated as potential indicators of a higher risk of persistent organ dysfunction plus death 7 days after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Elective or urgent pulmonary endarterectomy\n\nExclusion Criteria:\n\n* absolute or relative contraindication to the use of transesophageal echocardiography,\n* hepatic cirrhosis,\n* portal vein thrombosis,\n* concomitant coronary artery bypass grafting,\n* patient refusal or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT03197792', 'acronym': 'PVP-ETO-CPC', 'briefTitle': 'Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Chirurgical Marie Lannelongue'}, 'officialTitle': 'Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy', 'orgStudyIdInfo': {'id': 'P17-37813005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary endarterectomy patients', 'description': 'All patients', 'interventionNames': ['Other: All patients']}], 'interventions': [{'name': 'All patients', 'type': 'OTHER', 'description': 'TEE is performed before cardiopulmonary bypass (before the opening of the pericardium, if possible) and immediately after weaning from cardiopulmonary bypass and optimization of the hemodynamic status by the attending anesthesiologist. A detailed ultrasound examination including portal vein pulsatility, splenic vein pulsatility, right and left ventricular global longitudinal strain and right and left systolic and diastolic function is recorded. A measure of portal vein pulsatility using TTE is also recorded before the onset of general anesthesia and on the morning of the 7th postoperative day.\n\nOn the 7th postoperative day, the investigators will evaluate for the presence of the primary outcome, POD + death.', 'armGroupLabels': ['Pulmonary endarterectomy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'TRAORE AMINATA, CEC', 'role': 'CONTACT', 'email': 'a.traore@ccml.fr', 'phone': '+33140948664'}, {'name': 'MOORE ALEX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}], 'centralContacts': [{'name': 'TRAORE AMINATA, CEC', 'role': 'CONTACT', 'email': 'a.traore@ccml.fr', 'phone': '+33140948664'}], 'overallOfficials': [{'name': 'MOORE ALEX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOPITAL MARIE LANNELONGUE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of thoracic surgery', 'investigatorFullName': 'Olaf Mercier, MD, PhD', 'investigatorAffiliation': 'Centre Chirurgical Marie Lannelongue'}}}}