Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery

NCT06688994 | Active Not Recruiting

• 1 other identifier: 23-6027
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Kidney Injuries; Chronic Renal Diseases

Keywords

Chronic renal disease; Acute kidney injury; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery .

You may qualify if:

• ≥ 18 years
• Patients undergoing cardiac surgery
• Serum Creatinine measured with 28 days of surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

University Health Network-Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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: 23482451 RESULT

• 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.

  PMID: 20967888 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart A McCluskey, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)