VItamin D Metabolism in SEnescent Cardiac Surgery Patients

NCT ID: NCT01378221

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Coronary Artery Bypass Grafting; Heart Valve Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

cardiac surgery patients age 65 years and less

No interventions assigned to this group

Group 2

cardiac surgery patients aged 75 years and over

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jochen Börgermann, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany

Locations

Heart Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

References

Borgermann 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: 10.1097/CCM.0b013e31824e8c42.

Reference Type: RESULT

PMID: 22584760 (View on PubMed)

Other Identifiers

005

Identifier Type: -

Identifier Source: org_study_id