Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT03568357
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2017-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reoxygenation for Cyanotic Pediatric CHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013771', 'term': 'Tetralogy of Fallot'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'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': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2017-12-24', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Logistic Organ Dysfunction (PELOD-2) score', 'timeFrame': 'up to 30 days', 'description': 'the change in the updated Pediatric Logistic Organ Dysfunction (PELOD-2) score (PELOD-2 score; range, 0 to 33 points, with higher scores indicating more severe organ dysfunction)'}], 'secondaryOutcomes': [{'measure': 'low cardiac output syndrome', 'timeFrame': 'up to 30 days', 'description': 'Low cardiac output syndrome was defined as cardiac index \\< 2.2 L/min/m2 of BSA with central venous pressure \\>18 mmHg and mean arterial pressure \\< 50 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tetralogy of Fallot'], 'conditions': ['Tetralogy of Fallot']}, 'referencesModule': {'references': [{'pmid': '23804862', 'type': 'BACKGROUND', 'citation': 'Babu B, Bhat S, Prabuswamy HP, Kamalapurkar G, Kumar HV, Libu GK, Shilpa S, Lokesh BK. Controlling oxygenation during initiation of cardiopulmonary bypass: can it improve immediate postoperative outcomes in cyanotic children undergoing cardiac surgery? A prospective randomized study. World J Pediatr Congenit Heart Surg. 2012 Jul 1;3(3):310-6. doi: 10.1177/2150135111431843.'}, {'pmid': '11100757', 'type': 'BACKGROUND', 'citation': 'Matheis G, Abdel-Rahman U, Braun S, Wimmer-Greinecker G, Esmaili A, Seitz U, Bastanier CK, Moritz A, Hofstetter R. Uncontrolled reoxygenation by initiating cardiopulmonary bypass is associated with higher protein S100 in cyanotic versus acyanotic patients. Thorac Cardiovasc Surg. 2000 Oct;48(5):263-8. doi: 10.1055/s-2000-7879.'}, {'pmid': '33902450', 'type': 'DERIVED', 'citation': 'Yang JN, Zhang XM, Ma LY, Lu ZJ, Zheng SQ, Hamzah AW, Shao YF, Liu H, Liu GL. Effect of cardiopulmonary bypass reoxygenation on myocardial dysfunction following pediatric tetralogy of Fallot repair. BMC Cardiovasc Disord. 2021 Apr 26;21(1):210. doi: 10.1186/s12872-021-02033-2.'}]}, 'descriptionModule': {'briefSummary': 'Evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass.\n\nSeveral clinical and basic studies have identified that controlled oxygenation during the initiation of bypass significantly improved the cardiac adaptation and remodeling capacity than hyperoxic oxygenation strategy among cyanotic patients undergoing tetralogy of Fallot repair, as evidenced by these reduced myocardial gene expression profiles associated with reoxygenation injury.\n\nThe investigators designed the reoxygenation for pediatric cardiac surgery study to investigate the effect of reoxygenation during cardiopulmonary bypass on clinical outcomes in patients with cyanotic congenital heart disease .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The infants and young children aged 1 months to 18 years were eligible for enrolment in this study if they had echocardiography confirmed congenital heart diseases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The operation-naive infants and young children aged 1 months to 18 years old were eligible for enrolment if they were indicated for undergoing anticipated radical repair of cyanotic congenital heart disease with cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* The chromosomal defects, airway and parenchymal lung disease, immunodeficiency, blood transfusion during the current admission, previous cardiac operation, or the opinion of the treating physician that randomization would not be in the best interest of the patient (lack of equipoise)'}, 'identificationModule': {'nctId': 'NCT03568357', 'acronym': 'Reoxygenation', 'briefTitle': 'Reoxygenation for Cyanotic Pediatric CHD', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD', 'orgStudyIdInfo': {'id': 'TedaICH-ROC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reoxygenation', 'description': 'After one minute of full bypass, fraction of inspired oxygen (FiO2) in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 40%-80% adjusted reoxygenation to maintain PO2 in the range of 250mm Hg-300 mm Hg or more during the bypass.', 'interventionNames': ['Procedure: Reoxygenation']}], 'interventions': [{'name': 'Reoxygenation', 'type': 'PROCEDURE', 'description': 'After one minute of full bypass, fraction of inspired oxygen (FiO2) in conservative group was increased at increments of 0.1 per minute to reach an FiO2 target of 40% that was adjusted to maintain an arterial PO2 in the range of 250 mm Hg or less during the bypass, while FiO2 in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 80% adjusted to maintain PO2 in the range of 300 mm Hg or more, on the basis of arterial PO2 level measured via a point of care blood gas analyzer.', 'armGroupLabels': ['Reoxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300457', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '188012181613'}], 'facility': 'TEDA International Cardiovascular Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '8618801281613'}], 'overallOfficials': [{'name': 'Xiaocheng Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TEDA International Cardiovascular Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Peking Union Medical College'}}}}