Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02442050
Status:
TERMINATED
Last Update Posted:
2022-01-12
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Del Nido Cardioplegia Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712134', 'term': 'Del Nido cardioplegia solution'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to spontaneous sinus rhythm', 'timeFrame': 'Collected from beginning of surgery until transfer of patient out of the operating room.', 'description': 'Return to spontaneous sinus rhythm measured as yes or no'}, {'measure': 'Defibrillation requirement', 'timeFrame': 'Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.', 'description': '• Defibrillation requirement will be measured as:\n\n* Defibrillation needed after coronary reperfusion (Y/N)\n* Number of defibrillations required'}, {'measure': 'Hemodynamic instability', 'timeFrame': 'Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.', 'description': 'Measures as return to cardiopulmonary bypass (CPB) due to hemodynamic instability (Y/N)'}, {'measure': 'Change in blood troponin levels', 'timeFrame': 'Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery).', 'description': '• Blood troponin levels measured at:\n\n* Baseline prior to surgery\n* 2 hours after termination of cardiopulmonary bypass\n* 12 hours after admission to the Cardiac Intensive Care Unit\n* 24 hours after admission to the Cardiac Intensive Care Unit'}, {'measure': 'Inotropic requirement', 'timeFrame': 'Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.', 'description': '• Inotropic requirements will be measures as:\n\n* Inotropic pharmacologic support (Y/N)\n* Duration of inotropic support after cardiopulmonary bypass measured in hours'}], 'secondaryOutcomes': [{'measure': 'Post-Operative Clinical Outcomes', 'timeFrame': 'Assessed from beginning of surgery until patient discharge from hospital, an expected average of 9 days, or up to 30 days after surgery for select outcomes (see below).', 'description': 'Postoperative clinical outcomes, as defined by the Society of Thoracic Surgeons Adult Cardiac Surgical Database\n\n• Operative mortality and readmissions are assessed up to 30 days after surgery'}, {'measure': 'Ejection fraction at termination of CPB', 'timeFrame': 'During surgical procedure at the termination of CPB', 'description': 'Calculated ejection fraction at termination of Cardiopulmonary bypass (via TEE- in percentage)'}, {'measure': 'Total duration of CPB', 'timeFrame': 'Measured during surgery from start to end of CPB', 'description': 'Cardiopulmonary bypass duration measured as the total number of minutes.'}, {'measure': 'Total aortic cross clamp duration', 'timeFrame': 'Measured during surgery from start to end of aortic cross clamp', 'description': 'Aortic cross clamp duration measured as the total number of minutes.'}, {'measure': 'Amount of cardioplegia solution', 'timeFrame': 'Measured from start to end of surgery', 'description': 'Total amount of cardioplegia solution administered measured in mL'}, {'measure': 'Cardioplegia costs', 'timeFrame': 'Measured from start to end of surgery', 'description': 'Cardioplegia costs (US dollars) including:\n\n* Solution preparation\n* Disposables\n* Delivery system and associated tools'}, {'measure': 'Total expense of surgical stay', 'timeFrame': 'Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.', 'description': 'Total expenses incurred during entire patient length of hospital stay (US dollars)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CABG', 'valve surgery', 'cardioplegia', 'heart surgery', 'cardiac surgery', 'Cardio-Pulmonary Bypass', 'myocardial arrest', 'coronary artery bypass graft', 'CPB'], 'conditions': ['Cardiac Perfusion']}, 'descriptionModule': {'briefSummary': 'The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow for prolonged re-dosing intervals while providing equivalent myocardial protection. The use of del Nido solution has been used extensively in congenital heart surgery for over 25 years. The primary objective is to determine whether expanding this technique to adult cardiac surgery will confer significant benefits in both surgical workflow and patient clinical outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional recovery or clinical outcome, and (2) superior delivery to the current blood-based cardioplegia strategy in cost analyses.', 'detailedDescription': 'This prospective randomized controlled trial is designed for adult patients between the ages of 19-79 presenting for isolated CABG or single valve surgery, with or without CABG, requiring the use of Cardio-Pulmonary Bypass (CPB). Patients with previous cardiac surgery or requiring mechanical and pharmacologic support will be excluded from the study.\n\nSubjects randomized to the intervention group will receive del Nido cardioplegia solution during the aortic cross clamp period. The control group will receive whole-blood cardioplegia according to the Inova Fairfax Adult Cardioplegia protocol. Primary outcomes include clinical indicators for myocardial preservation such as serum troponin levels and the return of spontaneous rhythm. Surrogate primary endpoints for myocardial protection include the requirement for inotropic support and the need for defibrillation after coronary reperfusion. Secondary endpoints include post-operative clinical outcomes, duration of the aortic cross clamp period, and total expenses incurred during the patient length of stay.\n\nThe investigators will conduct non-inferiority analyses to examine the effect of cardioplegia treatment arm on clinical outcomes and complications. Analyses of binary outcomes will use a 5% non-inferiority margin and analyses of continuous outcomes will use a 10% non-inferiority margin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects able to receive and provide informed consent\n* Elective surgical procedures requiring CPB and myocardial arrest\n* Isolated coronary artery bypass graft (CABG) surgery or single valve surgery, with or without CABG\n\nExclusion Criteria:\n\n* Previous cardiac surgery\n* Patients with preoperative inotropic pharmacological support\n* Patients on preoperative mechanical circulatory support\n* Patients with an implanted pacemaker or implantable cardioverter defibrillator\n* Patients with non-isolated CABG or other non-CABG procedures with single valve surgery'}, 'identificationModule': {'nctId': 'NCT02442050', 'briefTitle': 'Del Nido Cardioplegia Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '#14-1653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'del Nido solution', 'description': 'Administering of cardioplegia using del Nido solution in eligible patients.', 'interventionNames': ['Other: del Nido solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blood-based cardioplegia', 'description': 'Administering of cardioplegia using current standard of care blood-based cardioplegia protocol.', 'interventionNames': ['Other: Blood-based cardioplegia']}], 'interventions': [{'name': 'del Nido solution', 'type': 'OTHER', 'description': '1.0-liter of del Nido Cardioplegia after the aortic cross-clamp is applied to the ascending aorta. Delivery of del Nido solution will be administered in a 1:4 ratio of blood:crystalloid at a temperature of 6-10 degrees centigrade.', 'armGroupLabels': ['del Nido solution']}, {'name': 'Blood-based cardioplegia', 'type': 'OTHER', 'description': 'An induction dose of whole blood cardioplegia ranging from 1.0-2.0 liters of solution will be given, with subsequent doses of cardioplegia every 20 minutes.', 'armGroupLabels': ['Blood-based cardioplegia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'CVTSA', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Heart and Vascular Institute', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Niv Ad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inova Fairfax Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}