VItamin D Metabolism in SEnescent Cardiac Surgery Patients

Coronary Artery Bypass Grafting Clinical Trial

— VISE  

Official title:

Vitamin D Metabolism in Senescent Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378221
• Other study ID #: 005
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: December 11, 2013
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2013
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of in-hospital mortality, cerebrovascular events, pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system. Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term mortality in patients with a high risk for cardiovascular disease. Mild renal impairment, insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly individuals. The present study aimed to investigate whether cardiac surgery exerts age-dependent effects on calciotropic hormones, components of the immune system, and inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger cardiac surgery patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age: <= 65 years and >= 75 years

• first elective cardiac surgery (bypass or combined bypass and heart valve surgery)

• written informed consent

Exclusion Criteria:

• emergency cardiac intervention

• primary hyperparathyreoidism

• primary and secondary hypoparathyreoidism

• daily vitamin D supplementation > 10 micrograms

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Heart Valve Surgery

Locations

Country	Name	City	State
Germany	Heart Center North Rhine-Westphalia	Bad Oeynhausen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Börgermann J, Lazouski K, Kuhn J, Dreier J, Schmidt M, Gilis-Januszewski T, Knabbe C, Gummert JF, Zittermann A. 1,25-Dihydroxyvitamin D fluctuations in cardiac surgery are related to age and clinical outcome*. Crit Care Med. 2012 Jul;40(7):2073-81. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients		change from baseline within 1 month after cardiac surgery	No