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OpenTrials
Completed

NCT Number: NCT01378221

VItamin D Metabolism in SEnescent Cardiac Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Acronym: VISE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2011
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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