Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01616069
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D000077464', 'term': 'Simendan'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic heart function', 'timeFrame': 'Two years', 'description': 'Assessment the systolic and diastolic heart function'}], 'secondaryOutcomes': [{'measure': 'Mortality after CABAG', 'timeFrame': 'Two years', 'description': 'Assessment mortality after CABAG'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CABG', 'Echocardiography', 'Heart Failure', 'Heart Function'], 'conditions': ['Cardiopulmonary Bypass Graft']}, 'referencesModule': {'references': [{'pmid': '22480207', 'type': 'RESULT', 'citation': 'Chung PC, Huang PC, Liu YF, Chen KB. Transesophageal echocardiography, more than a diagnostic tool: use during surgical ligation of coronary artery fistulae - a case report. J Cardiothorac Surg. 2012 Apr 6;7:28. doi: 10.1186/1749-8090-7-28.'}, {'pmid': '22459932', 'type': 'RESULT', 'citation': 'De Mey N, Couture P, Laflamme M, Denault AY, Perrault LP, Deschamps A, Rochon AG. Intraoperative changes in regional wall motion: can postoperative coronary artery bypass graft failure be predicted? J Cardiothorac Vasc Anesth. 2012 Jun;26(3):371-5. doi: 10.1053/j.jvca.2012.02.005. Epub 2012 Mar 28.'}, {'pmid': '22440381', 'type': 'RESULT', 'citation': 'Salgado Filho MF, Siciliano A, Siciliano A, Oliveira AJ, Salgado J, Palitot I. The importance of transesophageal echocardiography in heart harvesting for cardiac transplantation. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):262-8. doi: 10.1016/S0034-7094(12)70124-1.'}, {'pmid': '22004267', 'type': 'RESULT', 'citation': 'Fattouch K, Castrovinci S, Murana G, Novo G, Caccamo G, Bertolino EC, Sampognaro R, Novo S, Ruvolo G, Lancellotti P. Multiplane two-dimensional versus real time three-dimensional transesophageal echocardiography in ischemic mitral regurgitation. Echocardiography. 2011 Nov;28(10):1125-32. doi: 10.1111/j.1540-8175.2011.01528.x. Epub 2011 Oct 17.'}, {'pmid': '26655803', 'type': 'DERIVED', 'citation': 'Salgado Filho MF, Barral M, Barrucand L, Cavalcanti IL, Vercosa N. A Randomized Blinded Study of the Left Ventricular Myocardial Performance Index Comparing Epinephrine to Levosimendan following Cardiopulmonary Bypass. PLoS One. 2015 Dec 14;10(12):e0143315. doi: 10.1371/journal.pone.0143315. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://www.sba.com.br', 'label': 'Related Info'}, {'url': 'http://www.scahq.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a double blind randomization study, assessing hemodynamic response in patients who underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan will be assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sinusal ritmus\n* EF \\> 35%\n* Elective CABG surgery\n\nExclusion Criteria:\n\n* No accept\n* Severe valvular regurgitation or stenoses\n* Chest pain\n* Cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT01616069', 'briefTitle': 'Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Juiz de Fora'}, 'officialTitle': 'Assessment and Hemodynamic Response in CABG After Cardiopulmonary Bypass Using Intraoperative Transesophegeal Echocardiography', 'orgStudyIdInfo': {'id': '0362/14-12-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'epinephrine', 'description': 'Assessment of systolic and diastolic heart function during CABAG with CPB with levosimendan using TEE.', 'interventionNames': ['Drug: epinephrine and levosimendan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'levosimendan', 'description': 'Assessment of systolic and diastolic heart function during CABAG with CPB with epinephrine using TEE.', 'interventionNames': ['Drug: epinephrine and levosimendan']}], 'interventions': [{'name': 'epinephrine and levosimendan', 'type': 'DRUG', 'description': 'epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)', 'armGroupLabels': ['epinephrine', 'levosimendan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600-100', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Cardiology / Ministry of Health', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Marcello F Salgado Filho, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology/Ministry of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Juiz de Fora', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, {'name': 'National Institute of Cardiology/Ministry of Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marcello F Salgado Filho, MD', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}