VItamin D Metabolism in SEnescent Cardiac Surgery Patients

NCT01378221 | Completed Results

• 1 other identifier: 005
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

vitamin D; cardiac surgery; inflammation; immune system; age

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

cardiac surgery patients age 65 years and less

Group 2

cardiac surgery patients aged 75 years and over

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age: \<= 65 years and \>= 75 years
• first elective cardiac surgery (bypass or combined bypass and heart valve surgery)
• written informed consent

You may not qualify if:

• emergency cardiac intervention
• primary hyperparathyreoidism
• primary and secondary hypoparathyreoidism
• daily vitamin D supplementation \> 10 micrograms

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Heart Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

• 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.

  PMID: 22584760 RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Armin Zittermann
• Organization: Heart and Diabetes Center North Rhine-Westphalia, Germany

azittermann@hdz-nrw.de

+49 5731 97

Study Officials

• Jochen Börgermann, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: September 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 30, 2014
• Results First Posted: January 30, 2014

Record last verified: 2013-12

Locations

DE (1)