Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 8:51 PM
Study NCT ID:
NCT00610350
Status:
COMPLETED
Last Update Posted:
2008-02-07
First Post:
2008-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levosimendan and Myocardial Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-06', 'studyFirstSubmitDate': '2008-01-24', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': 'two weeks'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '3 weeks'}, {'measure': 'Tracheal intubation time', 'timeFrame': 'one week'}, {'measure': 'Inotropic support over the first 7 days', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levosimendan', 'pre-conditioning', 'cardiac surgery', 'myocardial function', 'contractility', 'heart', 'ischaemia'], 'conditions': ['Myocardial Protection']}, 'referencesModule': {'references': [{'pmid': '19151048', 'type': 'DERIVED', 'citation': 'Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* intention to perform first-time multi-vessel CABG\n\nExclusion Criteria:\n\n* unstable angina\n* valvular disease\n* diabetes mellitus treated with sulphonylurea drugs\n* renal failure\n* severe hepatic disease\n* severe chronic obstructive pulmonary disease\n* a history of prior CABG surgery\n* recent myocardial infarction (MI) within the previous month'}, 'identificationModule': {'nctId': 'NCT00610350', 'briefTitle': 'Levosimendan and Myocardial Protection', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'LV 2003'}, 'secondaryIdInfos': [{'id': 'LV-2003-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L', 'interventionNames': ['Drug: levosimendan']}, {'type': 'EXPERIMENTAL', 'label': 'P', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'levosimendan', 'type': 'DRUG', 'description': '24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB', 'armGroupLabels': ['L']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB', 'armGroupLabels': ['P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00155', 'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome "Sapienza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Vincenzo De Santis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College London Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Vincenzo De Santis', 'oldOrganization': 'University of Rome "Sapienza"'}}}}