Vitamin D and Outcome in Cardiac Surgery

NCT ID: NCT02192528

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3852 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-07-31

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

Conditions

Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cardiac surgical patients

patients undergoing a cardiac surgical procedure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• cardiac surgical patients aged 18 years and older

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Zittermann, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart & Diabetes Center North-Rhine Westfalia, Germany

Locations

Heart & Diabetes Center North-Rhine Westphalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 23315905 (View on PubMed)

Other Identifiers

008

Identifier Type: -

Identifier Source: org_study_id