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Vitamin D, Cardiac Surgery and Outcome (Vitop)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552382
First Posted: March 13, 2012
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
  Purpose
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.

Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Vitamin D and Clinical Outcome in Cardiac Surgical Patients

Resource links provided by NLM:


Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 4418
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac surgical patients
patients undergoing a cardiac surgical procedure

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cardiac surgical patients
Criteria

Inclusion Criteria:

  • cardiac surgical patients aged 18 years and older

Exclusion Criteria:

  • age < 18 years
  • heart transplant recipients
  • pacemaker or defibrillator implantation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552382


Locations
Germany
Heart and Diabetes Center NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Heart Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Principal Investigator: Armin Zittermann, PhD Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum
  More Information

Publications:
Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01552382     History of Changes
Other Study ID Numbers: 006
First Submitted: February 7, 2012
First Posted: March 13, 2012
Last Update Posted: August 11, 2016
Last Verified: December 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
vitamin D
25-hydroxyvitamin D
MACCE
mortality
cardiac
cerebrovascular

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents