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Vitamin D, Cardiac Surgery and Outcome

NCT ID: NCT01552382

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4418 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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cardiac surgical patients

patients undergoing a cardiac surgical procedure

No interventions assigned to this group

Eligibility Criteria

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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

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armin Zittermann, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum

Locations

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Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Heart Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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 RESULT
PMID: 23315905 (View on PubMed)

Other Identifiers

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006

Identifier Type: -

Identifier Source: org_study_id

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