Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-28 @ 12:17 AM
Study NCT ID:
NCT06688994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VITAMIN D METABOLITES AS BIOMARKERS FOR THE IDENTIFICATION OF KIDNEY INJURY IN CARDIAC 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function', 'timeFrame': 'Up to 1 month before surgery up until POD 7', 'description': 'serum creatinine (sCr) and vitamin D metabolites (specifically 25(OH)D3 and 1,25(OH)2D3) will be measured in the same blood sample to determine the incidence of AKI and CKD in patients undergoing cardiac surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic renal disease, acute kidney injury, vitamin D'], 'conditions': ['Acute Kidney Injuries', 'Chronic Renal Diseases']}, 'referencesModule': {'references': [{'pmid': '23482451', 'type': 'RESULT', 'citation': 'Chow EC, Quach HP, Vieth R, Pang KS. Temporal changes in tissue 1alpha,25-dihydroxyvitamin D3, vitamin D receptor target genes, and calcium and PTH levels after 1,25(OH)2D3 treatment in mice. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E977-89. doi: 10.1152/ajpendo.00489.2012. Epub 2013 Mar 12.'}, {'pmid': '20967888', 'type': 'RESULT', 'citation': 'Chow EC, Sondervan M, Jin C, Groothuis GM, Pang KS. Comparative effects of doxercalciferol (1alpha-hydroxyvitamin D(2)) versus calcitriol (1alpha,25-dihydroxyvitamin D(3)) on the expression of transporters and enzymes in the rat in vivo. J Pharm Sci. 2011 Apr;100(4):1594-604. doi: 10.1002/jps.22366. Epub 2010 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'We will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. We will include 20 patients in each of the following 3 groups based on serum creatinine measured within 28-days of surgery: 1) normal kidney function (eGFR \\> 60 mL/min, n=20), 2) moderate impaired kidney function, eGFR between 30 and 60 mL/min (n=20) and 3) severe kidney dysfunction eGFR \\< 30 mL/min (n=20).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* ≥ 18 years\n* Patients undergoing cardiac surgery\n* Serum Creatinine measured with 28 days of surgery\n\nExclusion Criteria\n\n* Exogeneous calcitriol (1,25(OH)2D3) intake\n* History of parathyroidectomy\n* Patients with liver or kidney cancer\n* Patients with liver disease (e.g. liver failure, cirrhosis)'}, 'identificationModule': {'nctId': 'NCT06688994', 'acronym': 'VITAL', 'briefTitle': 'VITAMIN D METABOLITES AS BIOMARKERS FOR THE IDENTIFICATION OF KIDNEY INJURY IN CARDIAC SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery', 'orgStudyIdInfo': {'id': '23-6027'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network-Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Stuart A McCluskey, MD, PhD', 'role': 'CONTACT', 'email': 'stuart.mccluskey@uhn.ca', 'phone': '416-340-4800 ext4221'}], 'overallOfficials': [{'name': 'Stuart A McCluskey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data from this study is unique to the study and analytical techniques used'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}