Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-29 @ 3:39 AM
Study NCT ID:
NCT07212595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2025-09-28', 'studyFirstSubmitQcDate': '2025-10-06', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of acute kidney injury on post-operative days 2, 3, or 4', 'timeFrame': 'From enrollment to post-operative day 4', 'description': 'The rate of participants randomized to the amino acid infusion developing acute kidney injury as defined by Kidney Disease Improving Global Outcomes (KDIGO) as Stage 1, 2, or 3 will be compared to the rate of acute kidney injury in the placebo group'}, {'measure': 'Rate of mechanical ventilation at 96 hours post-operatively', 'timeFrame': 'From enrollment to 96 hours post-operatively', 'description': 'Rate of participants randomized to the amino acid infusion needing invasive mechanical ventilation beyond 96 hours post-operatively from congenital cardiac surgery repair will be compared to the rate from the placebo group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Bypass', 'Pediatric', 'Acute Kidney Injury', 'Amino Acids'], 'conditions': ['Acute Kidney Injury', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'The goal of the BRAVE-HEART study is to learn if an amino acid infusion can reduce the risk of developing acute kidney injury after cardiac surgery in children. The main questions it aims to answer are:\n\n1. Does an amino acid infusion decrease the number of participants with acute kidney injury?\n2. Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery?\n\nResearchers will compare amino acids to a placebo (a look-alike substance that contains no drug) to see if amino acids decrease the number of participants with acute kidney injury.\n\nParticipants will receive an amino acid or placebo infusion for up to 72 hours starting during cardiac surgery and only while in the operating room or the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expected to be at high risk of developing acute kidney injury after cardiac surgery based on Age, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, and anticipated cardiopulmonary bypass time\n* Age less than or equal to 18 years\n* Weight greater than or equal to 5 kilograms\n\nExclusion Criteria:\n\n* Preoperative extracorporeal organ support\n* History of chronic kidney disease\n* Known or suspected inborn errors of amino acid metabolism\n* Known hypersensitivity to amino acids\n* Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \\> 3 times the upper limit of normal for age/gender\n* Preterm infants less than 6 months of age who were born at less than 36 weeks gestational age\n* Anuria at the time of randomization\n* Expected use of total parental nutrition (TPN) within the first 72 hours post-operatively'}, 'identificationModule': {'nctId': 'NCT07212595', 'acronym': 'BRAVE-HEART', 'briefTitle': 'Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy', 'orgStudyIdInfo': {'id': '001 - BRAVE-HEART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acid Acid Infusion', 'description': 'Amino Acid Infusion for up to 72 hours', 'interventionNames': ['Drug: Amino Acid infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Infusion', 'description': 'Placebo Infusion for up to 72 hours', 'interventionNames': ['Drug: Lactated ringers solution']}], 'interventions': [{'name': 'Amino Acid infusion', 'type': 'DRUG', 'otherNames': ['Trophamine(TM) 10%'], 'description': 'Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours', 'armGroupLabels': ['Acid Acid Infusion']}, {'name': 'Lactated ringers solution', 'type': 'DRUG', 'description': 'Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day', 'armGroupLabels': ['Placebo Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'email': 'kelli.krallman@cchmc.org', 'phone': '513-636-4837'}, {'name': 'Stuart Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Kelli Krallman, RN, BSN, MS', 'role': 'CONTACT', 'email': 'kelli.krallman@cchmc.org', 'phone': '513-636-4837'}], 'overallOfficials': [{'name': 'Stuart Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'With a small data set from a single center, there is a high risk of the participants being able to be re-identified with the details within the data set.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stuart Goldstein, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Congenital Heart Alliance of Cincinnati', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics; Director, Center for Acute Care Nephrology', 'investigatorFullName': 'Stuart Goldstein, MD', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}