Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT03144258
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microcirculatory alterations during cardiopulmonary bypass', 'timeFrame': 'december 2019', 'description': 'Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart defects', 'systemic microcirculation', 'laser Doppler perfusion imaging', 'cardiac corrective surgery'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.', 'detailedDescription': '• Specific objectives:\n\n* To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children.\n* To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery.\n* To investigate the effects of different anesthetic agents on microvascular reactivity during CPB.\n* To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity.\n* To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels.\n* To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines.\n* To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'infants and children with congenital heart defects scheduled to corrective cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants and children with congenital heart defects scheduled to corrective cardiac surgery\n\nExclusion Criteria:\n\n* age inferior to 3 months and superior to 6 years'}, 'identificationModule': {'nctId': 'NCT03144258', 'briefTitle': 'Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cardiology, Laranjeiras, Brazil'}, 'officialTitle': 'Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children', 'orgStudyIdInfo': {'id': 'CAAE 19201413.6.0000.5272'}}, 'contactsLocationsModule': {'locations': [{'zip': '22240-006', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Cardiology, Ministry of Health, Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Eduardo Tibirica, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Laranjeiras, Brazil', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Eduardo Tibirica, MD, PhD', 'investigatorAffiliation': 'National Institute of Cardiology, Laranjeiras, Brazil'}}}}