Vitamin D, Cardiac Surgery and Outcome

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01552382
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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.

Study Timeline

• Study First Submitted: 2012-02-07
• Study Start: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Status Verified: 2013-12
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4418

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
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

Trial Locations

Locations (2)

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

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