Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-07 @ 1:51 PM
Study NCT ID:
NCT01393418
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2011-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery
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': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal injury/Failure', 'timeFrame': '18 Hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erythropoietin', 'Cardiac Surgery', 'Renal Biomarker', 'Acute Kidney Injury', 'Hypothermic Circulatory Arrest'], 'conditions': ['Erythropoietin', 'Acute Kidney Injury', 'Renal Biomarker']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).", 'detailedDescription': 'Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.\n\nErythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.\n\nInvestigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac surgery patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgery with cardiopulmonary bypass with DHCA\n* Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL\n* Adult male and female patients 18 years and older\n\nExclusion Criteria:\n\n* VADS\n* Emergent cases\n* Prolonged hypoxemia before, during or after bypass\n* End stage renal disease\n* Patients receive erythropoietin receptor agonists'}, 'identificationModule': {'nctId': 'NCT01393418', 'acronym': 'EPO', 'briefTitle': 'Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'EPO: A Renal Biomarker After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'HUM41529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects undergoing cardiac surgery', 'interventionNames': ['Other: Cardiac Surgery']}], 'interventions': [{'name': 'Cardiac Surgery', 'type': 'OTHER', 'armGroupLabels': ['Subjects undergoing cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Yasser El Kouatli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer', 'investigatorFullName': 'Yasser Kouatli', 'investigatorAffiliation': 'University of Michigan'}}}}