Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 7:00 PM
Study NCT ID:
NCT04606056
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2020-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-01', 'studyFirstSubmitDate': '2020-10-25', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute kidney injury', 'timeFrame': '31 May 2020 to 30 June 2020', 'description': 'within 1 week after contrast exposure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravenous', 'contrast', 'acute kidney injury', 'computer tomography'], 'conditions': ['Acute Kidney Injury', 'Contrast-induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '23360737', 'type': 'BACKGROUND', 'citation': 'Davenport MS, Khalatbari S, Dillman JR, Cohan RH, Caoili EM, Ellis JH. Contrast material-induced nephrotoxicity and intravenous low-osmolality iodinated contrast material. Radiology. 2013 Apr;267(1):94-105. doi: 10.1148/radiol.12121394. Epub 2013 Jan 29.'}, {'pmid': '24475854', 'type': 'BACKGROUND', 'citation': 'McDonald JS, McDonald RJ, Carter RE, Katzberg RW, Kallmes DF, Williamson EE. Risk of intravenous contrast material-mediated acute kidney injury: a propensity score-matched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014 Apr;271(1):65-73. doi: 10.1148/radiol.13130775. Epub 2014 Jan 16.'}, {'pmid': '15464318', 'type': 'BACKGROUND', 'citation': 'Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.'}, {'pmid': '25917468', 'type': 'BACKGROUND', 'citation': 'Leow KS, Wu YW, Tan CH. Renal-related adverse effects of intravenous contrast media in computed tomography. Singapore Med J. 2015 Apr;56(4):186-93. doi: 10.11622/smedj.2015057.'}, {'pmid': '23579046', 'type': 'BACKGROUND', 'citation': 'Davenport MS, Khalatbari S, Cohan RH, Dillman JR, Myles JD, Ellis JH. Contrast material-induced nephrotoxicity and intravenous low-osmolality iodinated contrast material: risk stratification by using estimated glomerular filtration rate. Radiology. 2013 Sep;268(3):719-28. doi: 10.1148/radiol.13122276. Epub 2013 Apr 11.'}, {'pmid': '33015613', 'type': 'BACKGROUND', 'citation': 'Davenport MS, Perazella MA, Yee J, Dillman JR, Fine D, McDonald RJ, Rodby RA, Wang CL, Weinreb JC. Use of Intravenous Iodinated Contrast Media in Patients With Kidney Disease: Consensus Statements from the American College of Radiology and the National Kidney Foundation. Kidney Med. 2020 Jan 22;2(1):85-93. doi: 10.1016/j.xkme.2020.01.001. eCollection 2020 Jan-Feb.'}, {'pmid': '31473019', 'type': 'BACKGROUND', 'citation': 'Rudnick MR, Leonberg-Yoo AK, Litt HI, Cohen RM, Hilton S, Reese PP. The Controversy of Contrast-Induced Nephropathy With Intravenous Contrast: What Is the Risk? Am J Kidney Dis. 2020 Jan;75(1):105-113. doi: 10.1053/j.ajkd.2019.05.022. Epub 2019 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous iodinated contrast media is commonly used to enhance diagnostic yield of computer tomography (CT) scans in clinical medicine. However, the perceived risk of contrast-induced nephropathy (CIN) frequently limits its use. While CIN is often self-limiting, it can cause significant morbidity by prolonging admissions and rendering an at-risk individual dialysis dependent. CIN has long been observed and described in clinical studies. There is ample data on CIN after administration of intraarterial contrast, but evidence is less compelling when it comes to intravenous contrast. Increasing studies have called into question the actual risk of intravenous contrast media. Expert panels are suggesting that the risk could have been overstated, leading to contrast being withheld when indicated. There is paucity of local data on this particular issue. More real world data on the actual incidence and risk factors of AKI will be helpful to clinicians.\n\nThe investigators plan to conduct a single center, retrospective study, to determine the incidence and risk factors of post contrast AKI in contrast enhanced CT scans.', 'detailedDescription': "A single center, retrospective study will be conducted, looking into all patients who had contrast-enhanced CT scans done in a specified time period. Serum creatinine at baseline and at 48-72 hours post-contrast of the participants will be compared to determine presence of post contrast AKI (PC-AKI). Data on the participants' demographics, comorbidities, laboratory results and use of nephrotoxins will also be captured and analysed.\n\nThe primary objective of this study is to determine the incidence of AKI after intravenous contrast administration for contrast enhanced CT scans (CECT). The secondary objective is to identify risk factors of PC-AKI and possibly come up with a risk stratification system that can be utilized in clinical practice. The investigators hypothesize that there is significant risk of acute kidney injury after intravenous contrast media administration, but it lower than that in the setting of intraarterial contrast; and that risk factors of AKI may include: pre existing chronic kidney disease, diabetes, hypertension, proteinuria, use of nephrotoxins, age, increased dose of contrast."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient of an acute care hospital with clinical indications for contrast enchanced CT scans, meeting inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Underwent one or more CT scan in CGH in the stipulated study period\n2. CT scan done as an inpatient or outpatient of CGH\n3. Serum creatinine available less than 6 months before scan\n4. Serum creatinine available within 1 week after scan\n\nExclusion Criteria:\n\n1. Age 12 or below\n2. Dialysis dependent before scan (dialysis related charge code applied 24 months before scan)\n3. Baseline serum creatinine not available\n4. Post scan serum creatinine not available'}, 'identificationModule': {'nctId': 'NCT04606056', 'briefTitle': 'Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'A Single Center Observational Study- Incidence and Risk Factors of Acute Kidney Injury After Intravenous Contrast Enhanced Computed Tomography Scans', 'orgStudyIdInfo': {'id': '202005-00046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent contrast enhanced CT scans'}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Chang Yin Chionh, FASN', 'role': 'STUDY_CHAIR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}