Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00959569
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2009-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esmolol in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.', 'timeFrame': 'Hospital stay (approximately 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with ventricular fibrillation after cardiopulmonary bypass', 'timeFrame': '30 days and 1 year'}, {'measure': 'Number of patients with low cardiac output syndrome', 'timeFrame': '30 days and 1 year'}, {'measure': 'Number of patients requiring post-operative inotropic support', 'timeFrame': '30 days and 1 year'}, {'measure': 'peak postoperative cardiac troponin level', 'timeFrame': '30 days and 1 year'}]}, 'conditionsModule': {'keywords': ['esmolol', 'cardiac surgery', 'cardiac anesthesia', 'mortality', 'beta blockers', 'beta-blockers', 'cardiac protection'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '19297196', 'type': 'BACKGROUND', 'citation': 'Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.'}, {'pmid': '18334040', 'type': 'BACKGROUND', 'citation': 'Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.'}, {'pmid': '19538174', 'type': 'BACKGROUND', 'citation': 'Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.'}, {'pmid': '19185145', 'type': 'BACKGROUND', 'citation': 'Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.'}]}, 'descriptionModule': {'briefSummary': 'This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end diastolic diameter \\>60 mm and/or an ejection fraction \\<50%\n* written informed consent\n* age \\>18 years\n\nExclusion Criteria:\n\n* previous unusual response to esmolol\n* inclusion in other randomized studies\n* esmolol administration in the previous 30 days\n* emergency operation'}, 'identificationModule': {'nctId': 'NCT00959569', 'acronym': 'BREVI', 'briefTitle': 'Esmolol in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical', 'orgStudyIdInfo': {'id': 'GO/URC/ER/mm 459/DG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'esmolol', 'description': 'the study group will receive esmolol (1-3 mg/kg)', 'interventionNames': ['Drug: Esmolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normosaline', 'description': 'normosaline (same ml of the study drug)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esmolol', 'type': 'DRUG', 'otherNames': ['Beta-blocker; Beta blocker; breviblock'], 'description': 'esmolol (1-3 mg/kg) during cardiac surgery', 'armGroupLabels': ['esmolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normosaline (same ml of the study drug)', 'armGroupLabels': ['normosaline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Vita-Salute University', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giovanni Landoni', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}