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Vitamin D, Cardiac Surgery and Outcome (Vitop)

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ClinicalTrials.gov Identifier: NCT01552382
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

Tracking Information
First Submitted Date February 7, 2012
First Posted Date March 13, 2012
Last Update Posted Date August 11, 2016
Study Start Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 12, 2012)
  • duration of ventilatory support [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
  • intensive care unit stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
  • in-hospital stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D, Cardiac Surgery and Outcome
Official Title Vitamin D and Clinical Outcome in Cardiac Surgical Patients
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population cardiac surgical patients
Condition Cardiovascular Disease
Intervention Not Provided
Study Groups/Cohorts cardiac surgical patients
patients undergoing a cardiac surgical procedure
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2012)
4418
Original Actual Enrollment Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • cardiac surgical patients aged 18 years and older

Exclusion Criteria:

  • age < 18 years
  • heart transplant recipients
  • pacemaker or defibrillator implantation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01552382
Other Study ID Numbers 006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Heart and Diabetes Center North-Rhine Westfalia
Study Sponsor Heart and Diabetes Center North-Rhine Westfalia
Collaborators Not Provided
Investigators
Principal Investigator: Armin Zittermann, PhD Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum
PRS Account Heart and Diabetes Center North-Rhine Westfalia
Verification Date December 2013