Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery (VITAL)
January 30, 2026 updated by: University Health Network, Toronto
The investigators 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.
The investigators 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).
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network-Toronto General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients undergoing cardiac surgery .
Description
Inclusion Criteria
- ≥ 18 years
- Patients undergoing cardiac surgery
- Serum Creatinine measured with 28 days of surgery
Exclusion Criteria
- Exogeneous calcitriol (1,25(OH)2D3) intake
- History of parathyroidectomy
- Patients with liver or kidney cancer
- Patients with liver disease (e.g. liver failure, cirrhosis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function
Time Frame: Up to 1 month before surgery up until POD 7
|
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
|
Up to 1 month before surgery up until POD 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stuart A McCluskey, MD, PhD, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 12, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Actual)
November 14, 2024
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Acute Kidney Injury
- Renal Insufficiency, Chronic
Other Study ID Numbers
- 23-6027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data from this study is unique to the study and analytical techniques used
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.