Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-27 @ 2:22 PM
Study NCT ID:
NCT01369732
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2011-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094629', 'term': 'Dissection, Thoracic Aorta'}], 'ancestors': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tren125@yuhs.ac', 'phone': '82220193547', 'title': 'Dr. Yon Hee Shim', 'organization': 'Yonsei University College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Saline Group', 'description': 'We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Erythropoietin Group', 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Acute Kidney Injury Based on RIFLE Criteria', 'timeFrame': 'upto 7 days after surgery', 'description': 'Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'timeFrame': 'upto 1 month after surgery', 'description': 'Participants will be followed for the mortality, an expected average of 1 month after surgery.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'the Duration of Mechanical Ventilation', 'timeFrame': 'upto 2 weeks after surgery', 'description': 'Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'the Duration of ICU Stay', 'timeFrame': 'upto 2 weeks after surgery', 'description': 'Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'the Duration of Hospital Stay', 'timeFrame': 'upto 1 month after surgery', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Acute Kidney Injury Based on RIFLE Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Group', 'description': 'We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.'}, {'id': 'OG001', 'title': 'Erythropoietin Group', 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'upto 7 days after surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saline Group', 'description': 'We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.'}, {'id': 'FG001', 'title': 'Erythropoietin Group', 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at the university hospital between May 2011 and January 2013.', 'preAssignmentDetails': 'Six patients were dropped out regarding wrong dose-count of erythropoietin (n = 1), death within 24 hours after surgery (n = 2), and screening failure due to chronic kidney disease (n = 3).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saline Group', 'description': 'We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.'}, {'id': 'BG001', 'title': 'Erythropoietin Group', 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '12', 'groupId': 'BG000'}, {'value': '61', 'spread': '13', 'groupId': 'BG001'}, {'value': '63', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2011-06-03', 'resultsFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-24', 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury Based on RIFLE Criteria', 'timeFrame': 'upto 7 days after surgery', 'description': 'Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.'}, {'measure': 'Incidence of Acute Kidney Injury Based on RIFLE Criteria', 'timeFrame': 'upto 7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'upto 1 month after surgery', 'description': 'Participants will be followed for the mortality, an expected average of 1 month after surgery.'}, {'measure': 'the Duration of Mechanical Ventilation', 'timeFrame': 'upto 2 weeks after surgery', 'description': 'Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.'}, {'measure': 'the Duration of ICU Stay', 'timeFrame': 'upto 2 weeks after surgery', 'description': 'Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.'}, {'measure': 'the Duration of Hospital Stay', 'timeFrame': 'upto 1 month after surgery', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dissection of Thoracic Aorta']}, 'descriptionModule': {'briefSummary': 'During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.\n\nHowever, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults above age of 20\n2. Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest\n\nExclusion Criteria:\n\n1. pregnancy or lactation\n2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis\n3. past history of thoracic aortic surgery\n4. malignancy 5. preoperative acute kidney injury\n5. chronic renal replacement therapy\n6. allergy or hypersensitivity to erythropoetin\n7. history of erythropoetin treatment\n8. death during or one day after surgery\n9. no consent\n10. reoperation within seven days of the first surgery'}, 'identificationModule': {'nctId': 'NCT01369732', 'briefTitle': 'Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest', 'orgStudyIdInfo': {'id': '3-2011-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline group', 'description': 'We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.', 'interventionNames': ['Drug: saline']}, {'type': 'EXPERIMENTAL', 'label': 'erythropoietin group', 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.', 'interventionNames': ['Drug: recombinant human erythropoietin']}], 'interventions': [{'name': 'recombinant human erythropoietin', 'type': 'DRUG', 'otherNames': ['epocaine'], 'description': 'We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.', 'armGroupLabels': ['erythropoietin group']}, {'name': 'saline', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.', 'armGroupLabels': ['Saline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yon Hee Shim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}