Vitamin D and Outcome in Cardiac Surgery

Cardiovascular Disease Clinical Trial

— Calcitop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192528
• Other study ID #: 008
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: August 10, 2016
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3852
• Est. completion date: July 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiac surgical patients aged 18 years and older

Exclusion Criteria:

• age < 18 years

• heart transplant recipients

• pacemaker or defibrillator implantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Germany	Heart & Diabetes Center North-Rhine Westphalia	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Börgermann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major cardiac or cerebrovascular event (MACCE)	MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.	Patients will be followed for an average time of 14 days from cardiac surgery to discharge	No
Secondary	duration of ventilatory support		Patients will be followed for an average time of 14 days from cardiac surgery to discharge	No
Secondary	intensive care unit stay		Patients will be followed for an average time of 14 days from cardiac surgery to discharge	No
Secondary	in-hospital stay		Patients will be followed for an average time of 14 days from cardiac surgery to discharge	No
Secondary	infection		Patients will be followed for an average time of 14 days from cardiac surgery to discharge	No