Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT00127712
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2005-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Sponsor:
Organization:
Raw JSON
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'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amiodarone', 'description': 'Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '59'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of hospitalization', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amiodarone', 'description': 'Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of GI access to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 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{'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '8', 'groupId': 'BG000'}, {'value': '63', 'spread': '9', 'groupId': 'BG001'}, {'value': '62', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2005-08-04', 'resultsFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-02', 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Atrial Fibrillation Requiring Treatment', 'timeFrame': '7 days'}, {'measure': 'Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Length of Intensive Care Unit Stay', 'timeFrame': 'Duration of hospitalization'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Duration of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amiodarone', 'atrial fibrillation', 'surgical procedures, thoracic'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '19699916', 'type': 'RESULT', 'citation': 'Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized trial evaluating amiodarone for prevention of atrial fibrillation after pulmonary resection. Ann Thorac Surg. 2009 Sep;88(3):886-93; discussion 894-5. doi: 10.1016/j.athoracsur.2009.04.074.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:\n\n* Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;\n* Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and\n* Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.', 'detailedDescription': 'Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).\n\nA major complication of these non-cardiac open-chest surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following major non-cardiac open-chest surgery can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.\n\nAmiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females over the age of 40\n* Scheduled to undergo pneumonectomy or lobectomy\n\nExclusion Criteria:\n\n* History (hx) of atrial fibrillation\n* Prior severe side effects from amiodarone\n* Elevated liver enzymes \\>3 times the upper limit of normal (UNL)\n* QTc interval \\> 450 ms\n* Receiving class Ia or class III antiarrhythmics'}, 'identificationModule': {'nctId': 'NCT00127712', 'briefTitle': 'Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery', 'orgStudyIdInfo': {'id': '0407-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amiodarone', 'description': 'Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days', 'interventionNames': ['Drug: Amiodarone']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Patients in this group receive no intervention'}], 'interventions': [{'name': 'Amiodarone', 'type': 'DRUG', 'armGroupLabels': ['Amiodarone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'James E Tisdale, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Purdue University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Interim Head, Dept of Pharmacy Practice, Purdue University and Adjunct Professor, School of Medicine, Indiana University', 'investigatorFullName': 'James E. Tisdale', 'investigatorAffiliation': 'Purdue University'}}}}