Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-02 @ 3:25 PM
Study NCT ID:
NCT01807195
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Renal Injury Associated Contrast in Intensive Care Unit Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 886}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of acute renal damage associated with contrast media in intensive care patients', 'timeFrame': 'each time evaluation of contrast medium usage', 'description': 'The occurrence of acute renal damage was examined, and these patients were compared with the group that did not develop acute renal damage to investigate whether the use of contrast agents acts as an independent variable. In addition, the RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contrast', 'Intensive care unit', 'Acute kidney injury'], 'conditions': ['Acute Renal Injury']}, 'referencesModule': {'references': [{'pmid': '25780349', 'type': 'DERIVED', 'citation': 'Kim MH, Koh SO, Kim EJ, Cho JS, Na SW. Incidence and outcome of contrast-associated acute kidney injury assessed with Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients of medical and surgical intensive care units: a retrospective study. BMC Anesthesiol. 2015 Mar 3;15:23. doi: 10.1186/s12871-015-0008-x. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.\n\nExclusion Criteria:\n\n* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.'}, 'identificationModule': {'nctId': 'NCT01807195', 'briefTitle': 'Acute Renal Injury Associated Contrast in Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0922'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the medical records of those in whom a contrast medium', 'interventionNames': ['Other: contrast medium usage']}], 'interventions': [{'name': 'contrast medium usage', 'type': 'OTHER', 'armGroupLabels': ['the medical records of those in whom a contrast medium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}