Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 12:28 PM
Study NCT ID:
NCT04260204
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2020-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double-blind masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were included in the study if they had left to right shunt due to volume or pressure overload'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-02-01', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of postoperative peak air way pressure between the studied groups', 'timeFrame': '1 hour after surgery', 'description': 'peak air way pressure (Paw) in cmH2O'}, {'measure': 'Comparison of postoperative air way resistance between the studied groups', 'timeFrame': '1 hour after surgery', 'description': 'air way resistance (Raw) in cmH2O/L/sec.'}, {'measure': 'Comparison of postoperative Plateau pressure between the studied groups', 'timeFrame': '1 hour after surgery', 'description': 'Plateau pressure in cm H2O'}, {'measure': 'Comparison of postoperative Lung compliance between the studied groups', 'timeFrame': '1 hour after surgery', 'description': 'Lung compliance in L/cm H2O'}, {'measure': 'Comparison of postoperative Tidal volume between the studied groups', 'timeFrame': '1 hour after surgery', 'description': 'Tidal volume in ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retrograde autologous priming pulmonary mechanics'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.', 'detailedDescription': 'This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children complained of congenital heart disease with left to right shunt pressure or volume load\n\nExclusion Criteria:\n\n* cyanotic heart disease'}, 'identificationModule': {'nctId': 'NCT04260204', 'acronym': 'RAPCPB', 'briefTitle': 'Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': 'ACTS004367'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Retrograde priming', 'description': 'retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.', 'interventionNames': ['Procedure: Pediatric cardiac surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional priming', 'description': 'conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.', 'interventionNames': ['Procedure: Pediatric cardiac surgery']}], 'interventions': [{'name': 'Pediatric cardiac surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Retrograde priming', 'conventional priming']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hamdy Singab, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain shams university faculty of medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'Pulmonary mechanics improvement in pediatric patients undergoing cardiac surgery with retrograde autologous priming', 'accessCriteria': 'Pediatric cardiac surgeon'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Hamdy Singab', 'investigatorAffiliation': 'Ain Shams University'}}}}