Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 11:42 PM
Study NCT ID:
NCT05102734
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.greenwood@pennmedicine.upenn.edu', 'phone': '18568167172', 'title': 'Dr. John C. Greenwood', 'organization': 'Perelman School of Medicine at the University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Preoperative Control Group: During pre-operative imaging Topical Nitroglycerin Group: At postoperative baseline imaging through 30-minutes after topical nitroglycerin application', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Nitroglycerin', 'description': 'A topical nitroglycerin solution will be applied to the area of interest\n\nNitroglycerin Topical Product: Topical nitroglycerin solution', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Post-NTG Challenge', 'description': 'PVD response after NTG challenge', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perfused Vessel Density (PVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}, {'id': 'OG001', 'title': 'Topical Nitroglycerin Group Postop Baseline', 'description': 'Postop baseline measurement of PVD.\n\nA topical nitroglycerin solution will then be applied to the sublingual space.'}, {'id': 'OG002', 'title': 'Topical Nitroglycerin Group 3-minutes Post-NTG', 'description': 'PVD response 3 minutes after topical NTG solution application.'}, {'id': 'OG003', 'title': 'Topical Nitroglycerin Group 30-minutes Post-NTG', 'description': 'PVD measured 30 minutes after topical NTG solution application.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.81', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '20.44', 'spread': '3.38', 'groupId': 'OG001'}, {'value': '26.41', 'spread': '3.50', 'groupId': 'OG002'}, {'value': '21.88', 'spread': '3.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative Control Group: assessed once preoperatively. For the topical nitroglycerin group, PVD measurements were obtained after surgery (baseline), then 3-minutes and 30-minutes after topical nitroglycerin administration.', 'description': 'Estimate of functional capillary density.', 'unitOfMeasure': 'mm/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sublingual microcirculation measurements were obtained in a preoperative control group to serve as a "healthy" control measurement to compare against measurements in patients with shock. The preoperative control group only had one PVD measurement taken. Sublingual microcirculation measurements in the topical nitroglycerin group were measured after surgery (baseline), then 3-minutes and 30-minutes after NTG solution application.'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}, {'id': 'OG001', 'title': 'Topical Nitroglycerin Group Postop Baseline', 'description': 'Postop baseline measurement of PVD.\n\nA topical nitroglycerin solution will then be applied to the sublingual space.'}, {'id': 'OG002', 'title': 'Topical Nitroglycerin Group 3-minutes Post-NTG', 'description': 'PVD response 3 minutes after NTG solution application.'}, {'id': 'OG003', 'title': 'Topical Nitroglycerin Group 30-minutes Post-NTG', 'description': 'PVD 30 minutes after NTG solution application.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.85', 'spread': '11.67', 'groupId': 'OG000'}, {'value': '71.05', 'spread': '5.92', 'groupId': 'OG001'}, {'value': '70.35', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '74.4', 'spread': '7.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application.', 'description': 'Mean arterial blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Same groups as the primary outcome.'}, {'type': 'SECONDARY', 'title': 'Cardiac Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}, {'id': 'OG001', 'title': 'Topical Nitroglycerin Group Postop Baseline', 'description': 'Postop baseline measurement of PVD.\n\nA topical nitroglycerin solution will then be applied to the sublingual space.'}, {'id': 'OG002', 'title': 'Topical Nitroglycerin Group 3-minutes Post-NTG', 'description': 'PVD response 3 minutes after NTG solution application.'}, {'id': 'OG003', 'title': 'Topical Nitroglycerin Group 30-minutes Post-NTG', 'description': 'PVD 30 minutes after NTG solution application.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.54', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '2.88', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '2.83', 'spread': '0.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cardiac output was measured for the control group, then for the NTG group at postoperative baseline, 3-minuts, and 30-minutes after topical NTG application', 'description': 'Cardiac output relative to patients body surface area', 'unitOfMeasure': 'L/min/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Same groups as the primary outcome'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}, {'id': 'OG001', 'title': 'Topical Nitroglycerin Group Postop Baseline', 'description': 'Postop baseline measurement of PVD.\n\nA topical nitroglycerin solution will then be applied to the sublingual space.'}, {'id': 'OG002', 'title': 'Topical Nitroglycerin Group 3-minutes Post-NTG', 'description': 'PVD response 3 minutes after NTG solution application.'}, {'id': 'OG003', 'title': 'Topical Nitroglycerin Group 30-minutes Post-NTG', 'description': 'PVD 30 minutes after NTG solution application.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '9.35', 'spread': '3.79', 'groupId': 'OG001'}, {'value': '9.15', 'spread': '3.25', 'groupId': 'OG002'}, {'value': '9.16', 'spread': '3.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application', 'description': 'surrogate measure for right atrial pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Same as the primary outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Nitroglycerin', 'description': 'A topical nitroglycerin solution will be applied to the area of interest\n\nNitroglycerin Topical Product: Topical nitroglycerin solution'}, {'id': 'FG001', 'title': 'Preoperative Control Group', 'description': 'Subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not require vasopressors', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not have functioning PA catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Inadequate video quality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patient recruitment completed between August 1 and October 30, 2021.', 'preAssignmentDetails': '20 patients were enrolled to obtain preoperative control microcirculation measurements only. 20 additional patients would be needed for the NTG challenge. NTG patients were enrolled prior to surgery, but not included if they did not meet postop inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Nitroglycerin', 'description': 'A topical nitroglycerin solution will be applied to the area of interest\n\nNitroglycerin Topical Product: Topical nitroglycerin solution'}, {'id': 'BG001', 'title': 'Preoperative Control Group', 'description': '20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.'}, {'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': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'BG000'}, {'value': '67', 'spread': '11', 'groupId': 'BG001'}, {'value': '65', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', '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': '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-01', 'size': 70150, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-26T11:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2021-10-21', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-29', 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfused Vessel Density (PVD)', 'timeFrame': 'Preoperative Control Group: assessed once preoperatively. For the topical nitroglycerin group, PVD measurements were obtained after surgery (baseline), then 3-minutes and 30-minutes after topical nitroglycerin administration.', 'description': 'Estimate of functional capillary density.'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial Pressure', 'timeFrame': 'MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application.', 'description': 'Mean arterial blood pressure'}, {'measure': 'Cardiac Index', 'timeFrame': 'Cardiac output was measured for the control group, then for the NTG group at postoperative baseline, 3-minuts, and 30-minutes after topical NTG application', 'description': 'Cardiac output relative to patients body surface area'}, {'measure': 'Central Venous Pressure', 'timeFrame': 'CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application', 'description': 'surrogate measure for right atrial pressure'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circulatory Shock', 'Cardiovascular Shock']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. Participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective cardiovascular surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients receiving elective CABG or valvular surgery requiring cardiopulmonary bypass\n* Receiving postoperative catecholamine therapy to maintain a MAP \\> 65mmHg, cardiac index \\> 2 despite initial fluid resuscitation\n* Invasive hemodynamic monitoring\n\nExclusion Criteria:\n\n* Surgical hemorrhage\n* Unable to tolerate sublingual microcirculatory flow imaging\n* Known intolerance or allergy to nitroglycerin\n* Inadequate microcirculation imaging (based on Massey Score)'}, 'identificationModule': {'nctId': 'NCT05102734', 'briefTitle': 'Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.', 'orgStudyIdInfo': {'id': '843615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Topical nitroglycerin', 'description': 'A topical nitroglycerin solution will be applied to the area of interest', 'interventionNames': ['Drug: Nitroglycerin Topical Product']}], 'interventions': [{'name': 'Nitroglycerin Topical Product', 'type': 'DRUG', 'description': 'Topical nitroglycerin solution', 'armGroupLabels': ['Topical nitroglycerin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of the Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'John C. Greenwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'url': 'https://zenodo.org/record/5768720', 'infoTypes': ['CSR'], 'ipdSharing': 'YES', 'description': 'Publication of demographics, study drug effects, changes in hemodynamics and microcirculation. Limited, de-identified data can be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}