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NCT Number: NCT01552382

Vitamin D, Cardiac Surgery and Outcome

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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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center North Rhine-Westphalia, Bad Oeynhausen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardiac surgical patients aged 18 years and older

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. major cardiac or cerebrovascular event (MACCE)

    Time frame: 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 outcomes

  1. duration of ventilatory support

    Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge

  2. intensive care unit stay

    Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge

  3. in-hospital stay

    Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

Vitamin D and Clinical Outcome in Cardiac Surgical Patients

Acronym: Vitop

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2012
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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