Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 6:12 PM
Study NCT ID:
NCT00955266
Status:
TERMINATED
Last Update Posted:
2017-05-22
First Post:
2009-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002122', 'term': 'Calcium Chloride'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnurok@gmail.com', 'phone': '617-899-5961', 'title': 'Michael Nurok', 'organization': "Brigham & Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised contents of location need to be destroyed. As a result, data is not available for results reporting.'}}, 'adverseEventsModule': {'timeFrame': '1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diastolic Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.'}, {'type': 'SECONDARY', 'title': 'Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Return to Cardiopulmonary bypass Yes/ No', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.'}, {'type': 'SECONDARY', 'title': 'Need for Inotropic or Vasopressor Support Upon Leaving the OR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Use of inotropes or vasopressors in the Operating Room.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Hospital length of stay in days.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.'}, {'type': 'SECONDARY', 'title': 'Length of ICU Stay (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Intensive Care Unit length of stay in days.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcium Choloride', 'description': 'Calcium chloride, 10mg/kg\n\nCalcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline, 50cc delivered over 5 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 8}}, 'statusModule': {'whyStopped': 'Inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2009-07-30', 'resultsFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-10', 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic Dysfunction', 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability', 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Return to Cardiopulmonary bypass Yes/ No'}, {'measure': 'Need for Inotropic or Vasopressor Support Upon Leaving the OR', 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Use of inotropes or vasopressors in the Operating Room.'}, {'measure': 'Length of Hospital Stay (Days)', 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Hospital length of stay in days.'}, {'measure': 'Length of ICU Stay (Days)', 'timeFrame': '64 enrolled patients or 9 months following start of protocol, whichever comes first', 'description': 'Intensive Care Unit length of stay in days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Separation', 'Cardiopulmonary bypass', 'Calcium chloride'], 'conditions': ['Diastolic Dysfunction']}, 'descriptionModule': {'briefSummary': 'Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calcium can "jump start" the heart. Not every hospital does this.\n\nSome people think that calcium may have a side effect of making the heart more stiff. Stiff hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If calcium makes the heart stiff, then doctors may have to use other medicines to support the heart in the operating room and the intensive care unit. This may ultimately lead to poorer outcomes including a longer stay in the intensive care unit and in the hospital.\n\nThis study is being performed to find out if calcium has the side effect of making the heart more stiff. This study compares calcium to placebo. The placebo looks exactly like the calcium, but it contains no calcium. During this study patients may receive placebo instead of calcium. Neither the doctor nor the study team will know which drug the subject will receive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women greater than 18 years of age\n* Undergoing primary elective valve surgery at Brigham and Women's Hospital\n* Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring\n\nExclusion Criteria:\n\n* Patients not consented for TEE as part of routine intra-operative care\n* Any absolute contraindication to TEE\n* Ionized calcium level \\< 0.80 mmol/L near separation from CPB\n* Myocardial infarction (MI) or acute coronary syndromes \\< 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium\n* Ejection fraction (EF) \\< 35%\n* Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler\n* Heart rate (HR) \\> 100 during 2 data point collections due to E / A wave superimposition"}, 'identificationModule': {'nctId': 'NCT00955266', 'briefTitle': 'A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '2009-P-000052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium Chloride', 'description': 'Calcium chloride, 10mg/kg', 'interventionNames': ['Drug: Calcium Chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Calcium Chloride', 'type': 'DRUG', 'description': 'Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes', 'armGroupLabels': ['Calcium Chloride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline, 50cc delivered over 5 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham and Womens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael Nurok, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac Anesthesiologist', 'investigatorFullName': 'Michael Nurok, MD, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}