Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-21 @ 6:01 AM
Study NCT ID:
NCT00848250
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2009-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mias.pretorius@vanderbilt.edu', 'phone': '615-8757402', 'title': 'Mias Pretorius', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'While patients were randomized to preoperative ACE inhibition, the present study was neither blinded nor placebo-controlled. However, the dose and type of ACE inhibitor were similar between the two study groups.'}}, 'adverseEventsModule': {'timeFrame': 'From the start of surgery until hospital discharge, approximately 7 days', 'eventGroups': [{'id': 'EG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Permanent pacemaker', 'notes': 'Did the patient require a permanent pacemaker after surgery?', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'notes': 'Did the patient develop a pleural effusion?', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ECMO', 'notes': 'Extracorporeal membrane oxygenation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical re-exploration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '(PAI-1) Plasminogen Activator Inhibitor -1 Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Baseline, Pre- Cardiopulmonary bypass (CPD)', 'categories': [{'measurements': [{'value': '4.59', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'at 30 minutes on CPB', 'categories': [{'measurements': [{'value': '13.59', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'Completion of CPB', 'categories': [{'measurements': [{'value': '54.74', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '58.56', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1 (at 8:00AM)', 'categories': [{'measurements': [{'value': '57.13', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '88.74', 'spread': '14.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 't-PA (Tissue-type Plasminogen Activator) Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Baseline, Pre- Cardiopulmonary bypass (CPD)', 'categories': [{'measurements': [{'value': '10.81', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.31', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'On CPB for 30 minutes', 'categories': [{'measurements': [{'value': '12.97', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '20.44', 'spread': '6.38', 'groupId': 'OG001'}]}]}, {'title': 'At completion of CPB', 'categories': [{'measurements': [{'value': '16.83', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '28.03', 'spread': '3.15', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1 (at 8:00AM)', 'categories': [{'measurements': [{'value': '14.36', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '20.24', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IL-6 (Interleukin-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Baseline, Pre- Cardiopulmonary bypass (CPD)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'on CPB for 30min', 'categories': [{'measurements': [{'value': '9.64', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '13.08', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'At completion of CPB', 'categories': [{'measurements': [{'value': '215.84', 'spread': '32.59', 'groupId': 'OG000'}, {'value': '141.00', 'spread': '91.56', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1 (at 8:00AM)', 'categories': [{'measurements': [{'value': '401.69', 'spread': '123.66', 'groupId': 'OG000'}, {'value': '119.13', 'spread': '33.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-surgery) to postoperative day 1', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IL-8 (Interleukin-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Baseline (Before going on cardiopulmonary bypass', 'categories': [{'measurements': [{'value': '11.69', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '15.56', 'spread': '3.61', 'groupId': 'OG001'}]}]}, {'title': 'at 30 minutes on CPB', 'categories': [{'measurements': [{'value': '20.76', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '36.91', 'spread': '16.92', 'groupId': 'OG001'}]}]}, {'title': 'Admission to ICU following surgery', 'categories': [{'measurements': [{'value': '213.74', 'spread': '39.39', 'groupId': 'OG000'}, {'value': '244.86', 'spread': '121.13', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1 (at 8:00AM)', 'categories': [{'measurements': [{'value': '201.05', 'spread': '66.91', 'groupId': 'OG000'}, {'value': '127.03', 'spread': '42.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-surgery) to postoperative day 1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '(MAP) Mean Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Baseline, Pre- Cardiopulmonary bypass (CPD)', 'categories': [{'measurements': [{'value': '42.65', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '47.82', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'at 30 minutes on CPB', 'categories': [{'measurements': [{'value': '53.02', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '53.52', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'At completion of CPB', 'categories': [{'measurements': [{'value': '60.35', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '59.48', 'spread': '3.81', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 1 (at 8:00AM)', 'categories': [{'measurements': [{'value': '60.63', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '64.16', 'spread': '3.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'title': 'Chest tube output in 4 hrs', 'categories': [{'measurements': [{'value': '38.4', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Chest tube output in 24 hrs', 'categories': [{'measurements': [{'value': '76.3', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'P-value is for comparison of chest tube output at 24 hours', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Chest tube output at 4 and 24 hours after completion of surgery', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'OG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1', 'description': 'Acute kidney injury occurring', 'unitOfMeasure': 'Percentage of subject with AKI', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'FG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'surgery was completed without cardiopulm', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '29 participants were eligible, 8 refused participation'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACE Inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery\n\nAngiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery'}, {'id': 'BG001', 'title': 'No ACE Inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery\n\nNo ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '20.8', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '17.2', 'spread': '5.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2009-02-05', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(PAI-1) Plasminogen Activator Inhibitor -1 Antigen', 'timeFrame': 'Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1'}, {'measure': 't-PA (Tissue-type Plasminogen Activator) Antigen', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1'}], 'secondaryOutcomes': [{'measure': 'IL-6 (Interleukin-6)', 'timeFrame': 'Baseline (pre-surgery) to postoperative day 1'}, {'measure': 'IL-8 (Interleukin-8)', 'timeFrame': 'Baseline (pre-surgery) to postoperative day 1'}, {'measure': '(MAP) Mean Arterial Blood Pressure', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1'}, {'measure': 'Postoperative Bleeding', 'timeFrame': '24 hours', 'description': 'Chest tube output at 4 and 24 hours after completion of surgery'}, {'measure': 'Postoperative Renal Function', 'timeFrame': 'Baseline (prior to surgery) to postoperative day 1', 'description': 'Acute kidney injury occurring'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Bypass', 'ACE inhibitor', 'Pediatrics'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.\n* Patients must be taking an ACE inhibitor prior to their operation\n\nExclusion Criteria:\n\n* Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist\n* Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.\n* Pregnancy as ruled out by standard of care screening procedures.\n* Individuals whose weight is less than 3.5 kg at the time of enrollment.\n* Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.'}, 'identificationModule': {'nctId': 'NCT00848250', 'briefTitle': 'Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects', 'orgStudyIdInfo': {'id': '071078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACE inhibitor', 'description': 'Patients already on an ACE inhibitor will continue it until the day of surgery', 'interventionNames': ['Drug: Angiotensin Converting Enzyme Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'No ACE inhibitor', 'description': 'Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery', 'interventionNames': ['Other: No ACE Inhibitor']}], 'interventions': [{'name': 'Angiotensin Converting Enzyme Inhibitor', 'type': 'DRUG', 'description': 'Patients randomized to this group will continue their current dose of ACE inhibitors until surgery', 'armGroupLabels': ['ACE inhibitor']}, {'name': 'No ACE Inhibitor', 'type': 'OTHER', 'description': 'Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery', 'armGroupLabels': ['No ACE inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Monroe Carell Jr. Children's Hospital at Vanderbilt", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gregory A Fleming, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center, Division of Pediatric Cardiology'}, {'name': 'Mias Pretorius, MBChB, MSCI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center, Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gregory Fleming', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}