Vitamin D, Cardiac Surgery and Outcome (Vitop)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT01552382
First received: February 7, 2012
Last updated: December 12, 2013
Last verified: December 2013

February 7, 2012
December 12, 2013
March 2012
March 2012   (final data collection date for primary outcome measure)
major cardiac or cerebrovascular event (MACCE) [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ] [ Designated as safety issue: No ]
MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.
Same as current
Complete list of historical versions of study NCT01552382 on ClinicalTrials.gov Archive Site
  • duration of ventilatory support [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ] [ Designated as safety issue: No ]
  • intensive care unit stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ] [ Designated as safety issue: No ]
  • in-hospital stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D, Cardiac Surgery and Outcome
Vitamin D and Clinical Outcome in Cardiac Surgical Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

cardiac surgical patients

Cardiovascular Disease
Not Provided
cardiac surgical patients
patients undergoing a cardiac surgical procedure
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4418
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cardiac surgical patients aged 18 years and older

Exclusion Criteria:

  • age < 18 years
  • heart transplant recipients
  • pacemaker or defibrillator implantation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01552382
006
No
Heart and Diabetes Center North-Rhine Westfalia
Heart and Diabetes Center North-Rhine Westfalia
Not Provided
Principal Investigator: Armin Zittermann, PhD Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum
Heart and Diabetes Center North-Rhine Westfalia
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP