Clinical trial NCT02192528: Vitamin D and Outcome in Cardiac Surgery
Official title: 25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: vitamin D
25-hydroxyvitamin D
1,25-dihydroxyvitamin D
MACCE
mortality
cardiac
cerebrovascular
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 3852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cardiac surgical patients

Brief summary: We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will assess the association of the two vitamin D metaboolites with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D metabolite levels.

Detailed description: In a retrospective data analysis, we will evaluate the association of vitamin D metabolites (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will also assess the association of vitamin D metabolite levels with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status

Eligibility criteria: Inclusion Criteria:

* cardiac surgical patients aged 18 years and older

Exclusion Criteria:

* age \< 18 years
* heart transplant recipients
* pacemaker or defibrillator implantation

Primary outcomes:
measure: major cardiac or cerebrovascular event (MACCE)
timeFrame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
Secondary outcomes:
measure: duration of ventilatory support
timeFrame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: intensive care unit stay
timeFrame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: in-hospital stay
timeFrame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: infection
timeFrame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart & Diabetes Center North-Rhine Westphalia
state: NRW
Study officials:
affiliation: Heart & Diabetes Center North-Rhine Westfalia, Germany
name: Armin Zittermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann J. Vitamin D status and the risk of major adverse cardiac and cerebrovascular events in cardiac surgery. Eur Heart J. 2013 May;34(18):1358-64. doi: 10.1093/eurheartj/ehs468. Epub 2013 Jan 12.