Coronary Artery Bypass Grafting, Heart Valve Surgery
Conditions
Keywords
vitamin D, cardiac surgery, inflammation, immune system, age
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.
Interventions
None listed
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 cardiac surgery patients age 65 years and less | 29 |
| Group 2 cardiac surgery patients aged 75 years and over | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous Age | 58.8 years STANDARD_DEVIATION 5.92 | 77.0 years STANDARD_DEVIATION 4.38 | 68.05 years STANDARD_DEVIATION 5.14 |
| Region of Enrollment Germany | 29 participants | 30 participants | 59 participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients | 13 percentage | Standard Error 1.1 |
| Group 2 | Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients | 4.2 percentage | Standard Error 0.2 |