Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-29 @ 5:33 AM
Study NCT ID:
NCT04172103
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2009}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new-onset chronic kidney disease stage 3 or higher or mortality', 'timeFrame': 'during 3 years after surgery', 'description': 'development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 3 years after surgery. The new-onset chronic kidney disease was defined by at least two estimated Glomerular Filtration Rate values \\<60 ml/min/1.73 m2 separated by an interval of at least three months.'}], 'secondaryOutcomes': [{'measure': 'new-onset chronic kidney disease stage 3 or higher or mortality', 'timeFrame': 'during 1 year after surgery', 'description': 'development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 1 year after surgery'}, {'measure': 'new-onset chronic kidney disease stage 3 or higher or mortality', 'timeFrame': 'during 2 years after surgery', 'description': 'development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 2 years after surgery'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': 'during one month after surgery', 'description': 'Length of postoperative hospital stay'}, {'measure': 'Length of postoperative intensive care unit stay', 'timeFrame': 'during one month after surgery', 'description': 'Length of postoperative intensive care unit stay'}, {'measure': 'intra-aortic balloon pulsation insertion', 'timeFrame': 'during surgery and postoperative one week', 'description': 'intra-aortic balloon pulsation insertion'}, {'measure': 'Reopen for surgical bleeding', 'timeFrame': 'during one month after surgery', 'description': 'Reopen for surgical bleeding'}, {'measure': 'Respiratory complication', 'timeFrame': 'during one month after surgery', 'description': 'a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax'}, {'measure': 'in-hospital mortality', 'timeFrame': 'during one month after surgery', 'description': 'all-cause mortality during hospital stay'}, {'measure': 'Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2', 'timeFrame': 'at three months after surgery', 'description': 'Incidence of estimated Glomerular Filtration Rate \\<60 mL/min/1.73m2'}, {'measure': 'Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2', 'timeFrame': 'at one year after surgery', 'description': 'Incidence of estimated Glomerular Filtration Rate \\<60 mL/min/1.73m2'}, {'measure': 'Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2', 'timeFrame': 'at two years after surgery', 'description': 'Incidence of estimated Glomerular Filtration Rate \\<60 mL/min/1.73m2'}, {'measure': 'Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2', 'timeFrame': 'at three years after surgery', 'description': 'Incidence of estimated Glomerular Filtration Rate \\<60 mL/min/1.73m2'}, {'measure': 'Dependence on the regular hemodialysis', 'timeFrame': 'at three years after surgery', 'description': 'Dependence on the regular hemodialysis'}, {'measure': 'estimated Glomerular Filtration Rate', 'timeFrame': 'at three months after surgery', 'description': 'estimated Glomerular Filtration Rate'}, {'measure': 'estimated Glomerular Filtration Rate', 'timeFrame': 'at one year after surgery', 'description': 'estimated Glomerular Filtration Rate'}, {'measure': 'estimated Glomerular Filtration Rate', 'timeFrame': 'at two years after surgery', 'description': 'estimated Glomerular Filtration Rate'}, {'measure': 'estimated Glomerular Filtration Rate', 'timeFrame': 'at three years after surgery', 'description': 'estimated Glomerular Filtration Rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute kidney injury', 'chronic kidney disease', 'cardiac surgery', 'thoracic aortic surgery'], 'conditions': ['Acute Kidney Injury', 'Chronic Kidney Disease, Stage 3', 'Chronic Kidney Disease, Stage 5', 'Cardiac Surgery', 'Thoracic Aortic Surgery']}, 'referencesModule': {'references': [{'pmid': '28869251', 'type': 'BACKGROUND', 'citation': 'Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.'}, {'pmid': '24988558', 'type': 'BACKGROUND', 'citation': 'Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.6084/m9.figshare.10326734.v1', 'label': 'Statistical analysis plan'}]}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.', 'detailedDescription': 'Postoperative acute kidney injury (AKI) has been investigated as an important contributor to postoperative morbidity and mortality after cardiovascular surgery. Also, temporary worsening of renal function after aortic surgery is associated with higher long-term mortality. Although the associations between AKI and chronic kidney disease (CKD) in medical or other surgical settings were reported, only a few studies evaluated this relationship in patients undergoing cardiac surgery. More specifically, the association of the severity or duration of AKI with the risk of the development of new-onset CKD after cardiac surgery has not been clearly elucidated.\n\nIt would be important to find predictors of the long-term renal function or risk factors for the development of CKD after cardiac surgery because postoperative management of high-risk patients to develop long-term renal dysfunction may prevent further deterioration in renal function and improve patient prognosis.\n\nThe investigators aimed to evaluate (1) the long-term renal function after cardiac surgery and (2) the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective cohort of the adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017\n\nExclusion Criteria:\n\n* Those with off-pump coronary artery bypass\n* Missing baseline serum creatinine\n* Missing postoperative serum creatinine values of more than three among seven postoperative days\n* Preoperative baseline chronic kidney disease with estimated glomerular filtration rate \\<60 ml/min/1.73m2'}, 'identificationModule': {'nctId': 'NCT04172103', 'briefTitle': 'The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery: a Retrospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '1909-115-1066'}}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Ho Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}