Vitamin D and Outcome in Cardiac Surgery

25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02192528

Acronym

Calcitop

Enrollment

3852

Registered

2014-07-16

Start date

2012-06-30

Completion date

2014-07-31

Last updated

2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

vitamin D, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, MACCE, mortality, cardiac, cerebrovascular

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* cardiac surgical patients aged 18 years and older

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
major cardiac or cerebrovascular event (MACCE)	Patients will be followed for an average time of 14 days from cardiac surgery to discharge	MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.

Secondary

Measure	Time frame
duration of ventilatory support	Patients will be followed for an average time of 14 days from cardiac surgery to discharge
intensive care unit stay	Patients will be followed for an average time of 14 days from cardiac surgery to discharge
in-hospital stay	Patients will be followed for an average time of 14 days from cardiac surgery to discharge
infection	Patients will be followed for an average time of 14 days from cardiac surgery to discharge

Countries

Germany

Outcome results