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VItamin D Metabolism in SEnescent Cardiac Surgery Patients (VISE)

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ClinicalTrials.gov Identifier: NCT01378221
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

Study Description
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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.

Condition or disease
Coronary Artery Bypass Grafting Heart Valve Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Metabolism in Senescent Cardiac Surgery Patients
Study Start Date : September 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

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Groups and Cohorts
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Group/Cohort
Group 1
cardiac surgery patients age 65 years and less
Group 2
cardiac surgery patients aged 75 years and over


Outcome Measures
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Primary Outcome Measures :
  1. Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients [ Time Frame: change from baseline within 1 month after cardiac surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
elective cardiac surgery patients receiving isolated coronary artery bypass grafting or combined coronary artery bypass grafting and heart valve surgery
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378221


Locations
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Germany
Heart Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
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Principal Investigator: Jochen Börgermann, MD Heart Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany
More Information
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Publications of Results:

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Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01378221    
Other Study ID Numbers: 005
First Posted: June 22, 2011    Key Record Dates
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014
Last Verified: December 2013
Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
vitamin D
cardiac surgery
inflammation
immune system
age