Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 11:33 PM
Study NCT ID:
NCT00654992
Status:
COMPLETED
Last Update Posted:
2009-06-16
First Post:
2008-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C103998', 'term': 'epoetin beta'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyna@snubh.org', 'phone': '82-31-787-7014', 'title': 'Effect of erythropoietin in kidney after cardiac surgery', 'organization': 'Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erythropoietin (EPO) Group', 'description': 'received 300 U/kg of erythropoietin intraveously following induction of anesthesia'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'received normal saline intraveously following induction of anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the first 5 days after surgery', 'description': 'estimated glomerular filtration rate (eGFR)as ml/min/1.73m2', 'unitOfMeasure': 'ml/min/1.73m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had AKI (Acute Kidney Injury)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erythropoietin (EPO) Group', 'description': 'received 300 U/kg of erythropoietin intraveously following induction of anesthesia'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'received normal saline intraveously following induction of anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at any time within the first 5 days after surgery', 'description': 'number of participants who had 50% increase in serum creatinine levels from baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erythropoietin (EPO) Group', 'description': 'received 300 U/kg of erythropoietin intraveously following induction of anesthesia'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'received normal saline intraveously following induction of anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Erythropoietin (EPO) Group', 'description': 'received 300 U/kg of erythropoietin intraveously following induction of anesthesia'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'received normal saline intraveously following induction of anesthesia'}, {'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': '0.0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29.0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '11', 'groupId': 'BG000'}, {'value': '69', 'spread': '8', 'groupId': 'BG001'}, {'value': '67', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '53.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2008-04-04', 'resultsFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2008-04-04', 'lastUpdatePostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-28', 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had AKI (Acute Kidney Injury)', 'timeFrame': 'at any time within the first 5 days after surgery', 'description': 'number of participants who had 50% increase in serum creatinine levels from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'during the first 5 days after surgery', 'description': 'estimated glomerular filtration rate (eGFR)as ml/min/1.73m2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Failure, Acute']}, 'referencesModule': {'references': [{'pmid': '39301879', 'type': 'DERIVED', 'citation': 'Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.', 'detailedDescription': 'Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective CABG over age 18\n\nExclusion Criteria:\n\n* Under age 18\n* Emergent CABG\n* Prior exposure to nephrotoxic drug\n* Dialysis patients\n* Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT00654992', 'acronym': 'EPO-CABG', 'briefTitle': 'Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Prevention of Acute Kidney Injury (AKI) by Erythropoietin (EPO) in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial', 'orgStudyIdInfo': {'id': 'SNUBH B-0608/036-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EPO group', 'interventionNames': ['Drug: Erythropoietin-Beta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Erythropoietin-Beta', 'type': 'DRUG', 'otherNames': ['recormon'], 'description': '300 IU/kg of EPO or saline intravenously before surgery', 'armGroupLabels': ['EPO group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['0.9% saline'], 'description': '300 IU/kg of normal saline intravenously before surgery', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Ki Young, Na, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ki Young Na/MD PhD', 'oldOrganization': 'Department of Internal Medicine'}}}}