VItamin D Metabolism in SEnescent Cardiac Surgery Patients

Completed

• Conditions: Coronary Artery Bypass Grafting; Heart Valve Surgery

• Registration Number: NCT01378221
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Status Verified: 2013-12
• Results First Submitted: 2013-12-11
• Results First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Results First Posted: 2014-01-30
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Heart Center North Rhine-Westphalia; 🇩🇪 Bad Oeynhausen, North Rhine-Westphalia, Germany