Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-04 @ 3:13 PM
Study NCT ID:
NCT01401218
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic 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': 'D057286', 'term': 'Electronic Health Records'}], 'ancestors': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 799}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-22', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of Acute kidney injury', 'timeFrame': '1 time, within 48 hours of aortic surgery', 'description': 'diagnosis of AKI if the record of patient meet one of the below criteria\n\n1. abrupt (within 48 hours) reduction in kidney function currently defined as\n2. absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l),\n3. a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or\n4. a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thoracic aortic surgery', 'acute kidney injury'], 'conditions': ['Thoracic Aortic Surgery']}, 'descriptionModule': {'briefSummary': 'Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network. The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.', 'detailedDescription': 'Significant improvement of morbidity and mortality has been achieved during last three decades since developing deep hypothermic circulatory arrest (DHCA). However,postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network (2007). The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent thoracic aortic surgery durung 1994 to 2010 period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent thoracic aortic surgery during 1994 to 2010 period\n\nExclusion Criteria:\n\n* patients who had previous renal failure before aortic surgery'}, 'identificationModule': {'nctId': 'NCT01401218', 'briefTitle': 'Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery', 'orgStudyIdInfo': {'id': '2011-06-077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thoracic aortic surgery group', 'description': 'patients who underwent thoracic aortic surgery', 'interventionNames': ['Other: Electronic Medical Record (EMR) Review']}], 'interventions': [{'name': 'Electronic Medical Record (EMR) Review', 'type': 'OTHER', 'otherNames': ['Electronic Medical Record (EMR)'], 'description': "measurements of potential risk factors of acute kidney injury through the patients' previous medical record review.\n\npotential risk factors include previous history of hypertension, diabetes, cerebrovascular events, peripheral arterial disease, chronic obstructive pulmonary disease, recent myocardial infarction, coronary artery disease; preoperative glomerular filtration rate, preoperative creatinine level, preoperative cardiac ejection fraction reported on echocardiography, use of preoperative inotropics, use of deep hypothermic cardiac arrest, intraoperative colloid use, intraoperative blood product transfusion, total time of cardiopulmonary bypass,", 'armGroupLabels': ['thoracic aortic surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sangmin M. Lee, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sangmin M. Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}