Clinical trial NCT01552382: Vitamin D, Cardiac Surgery and Outcome
Official title: Vitamin D and Clinical Outcome in Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: vitamin D
25-hydroxyvitamin D
MACCE
mortality
cardiac
cerebrovascular
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 4418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cardiac surgical patients

Brief summary: We will use a retrospective data analysis to evaluate the association of vitamin D status 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 vitamin D status 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.

Detailed description: In a retrospective data analysis, we will evaluate the association of vitamin D status (circulating 25-hydroxyvitamin 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 4,500 data sets from January 2010 until the end of 2011 will be analyzed.In all patients, we will also assess the association of vitamin D status 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
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
state: North Rhine-Westphalia
city: Bad Oeynhausen
country: Germany
facility: Heart Center North Rhine-Westphalia
state: North Rhine-Westphalia
Study officials:
affiliation: Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum
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.