Vitamin D and Outcome in Cardiac Surgery

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT02192528
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-11
• Status Verified: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3852

Inclusion Criteria

• cardiac surgical patients aged 18 years and older

Exclusion Criteria

• age < 18 years
• heart transplant recipients
• pacemaker or defibrillator implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
duration of ventilatory support	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
intensive care unit 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

Trial Locations

Locations (1)

Heart & Diabetes Center North-Rhine Westphalia; 🇩🇪 Bad Oeynhausen, NRW, Germany