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
  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 ] [ Designated as safety issue: No ]
    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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552382

Locations
Germany
Heart Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Heart and Diabetes Center NRW
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
Study First Received: February 7, 2012
Last Updated: December 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014