Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04216927
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2019-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NO During CPB in Neonates to Reduce Risk of AKI
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}, {'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '• This pilot study is a single center, double-blind, randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-31', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AKI', 'timeFrame': '72 hours', 'description': 'Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification'}], 'secondaryOutcomes': [{'measure': 'Biomarker evidence of AKI - NGAL', 'timeFrame': '72 hours', 'description': 'Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker neutrophil gelatinase-associated lipocalin (NGAL)'}, {'measure': 'Biomarker evidence of AKI - KIM-1', 'timeFrame': '72 hours', 'description': 'Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker kidney injury molecule-1 (KIM-1)'}, {'measure': 'Biomarker evidence of AKI - IL-18', 'timeFrame': '72 hours', 'description': 'Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker interleukin-18 (IL-18)'}, {'measure': 'Biomarker evidence of AKI - L-FABP', 'timeFrame': '72 hours', 'description': 'Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker liver-type fatty acid-binding protein (L-FABP)'}, {'measure': 'Biomarker evidence of AKI - urinary nitrite', 'timeFrame': '72 hours', 'description': 'Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker urinary nitrate.'}, {'measure': 'Impact on GFR', 'timeFrame': '72 hours', 'description': 'Postoperative GFR measured using serum cystatin C.'}, {'measure': 'Low Cardiac Output', 'timeFrame': '48 hours', 'description': 'Incidence of low cardiac output syndrome (LCOS) during the first 48 hours postoperative'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AKI', 'CHD - Congenital Heart Disease', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '31 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.\n\nExclusion Criteria:\n\n1. Failure to obtain informed consent from parent/guardian\n2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,\n3. Emergency surgery,\n4. Episode of cardiac arrest within 1 week before surgery,\n5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),\n6. Use of inhaled NO (iNO) immediately prior to surgery,\n7. Structural renal abnormalities by ultrasound,\n8. Preoperative AKI,\n9. Use of other investigational drugs,\n10. Weight less than \\<2 kg,\n11. Gestational age \\<36 weeks,\n12. Major extracardiac congenital anomalies,\n13. Non-English speakers.'}, 'identificationModule': {'nctId': 'NCT04216927', 'briefTitle': 'NO During CPB in Neonates to Reduce Risk of AKI', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'MOD00004808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitric Oxide', 'description': 'Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care', 'interventionNames': ['Drug: Nitric Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oxygen', 'description': 'Standard CPB without NO administered at any point intraoperatively', 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'description': 'gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit', 'armGroupLabels': ['Nitric Oxide']}, {'name': 'Oxygen', 'type': 'DRUG', 'description': 'Oxygen alone will be entrained for placebo arm', 'armGroupLabels': ['Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David S. Cooper, MD', 'role': 'CONTACT', 'email': 'David.Cooper@cchmc.org', 'phone': '5138035448'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'David S Cooepr, MD', 'role': 'CONTACT', 'email': 'David.Cooper@cchmc.org', 'phone': '5138035448'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, {'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}