Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04882202
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acetaminophen and AKI After Aortic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest', 'timeFrame': 'Postoperative 7 days', 'description': 'Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Surgery']}, 'referencesModule': {'references': [{'pmid': '24732290', 'type': 'BACKGROUND', 'citation': 'Simpson SA, Zaccagni H, Bichell DP, Christian KG, Mettler BA, Donahue BS, Roberts LJ 2nd, Pretorius M. Acetaminophen attenuates lipid peroxidation in children undergoing cardiopulmonary bypass. Pediatr Crit Care Med. 2014 Jul;15(6):503-10. doi: 10.1097/PCC.0000000000000149.'}]}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is commonly accompanied major complication after aortic surgery.\n\nCardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death.\n\nAcetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.\n\nExclusion Criteria:\n\n1. patients with chronic kidney disease or with dialysis, eGFR \\< 15ml/min/1.73m2\n2. allergy to acetaminophen or propacetamol HCl\n3. history of liver cirrhosis or total bilirubin \\> 2.0mg/dL\n\n3\\) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent'}, 'identificationModule': {'nctId': 'NCT04882202', 'briefTitle': 'Acetaminophen and AKI After Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest', 'orgStudyIdInfo': {'id': '3-2021-0087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen group', 'description': 'patients receiving acetaminophen', 'interventionNames': ['Drug: Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'patients receiving equal amount of normal saline', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Acetaminophen 1g IV every 6 hours for a weight \\> 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight \\< 50kg (maximum of 75mg/kg per 24 hours)', 'armGroupLabels': ['Acetaminophen group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SungYeon Ham', 'role': 'CONTACT', 'email': 'SYID0424@yuhs.ac', 'phone': '82-2-2019-4601'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'SungYeon Ham', 'role': 'CONTACT', 'email': 'SYID0424@yuhs.ac', 'phone': '82-2-2019-4601'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sung Yeon Ham', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}