Vitamin D and Outcome in Cardiac Surgery

NCT02192528 | Completed

• 1 other identifier: 008
• Study Type: observational
• Target: 3,852
• Locations: 1 country
• Sites: 1

Brief Summary

We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D 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 the two vitamin D metaboolites 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 metabolite levels.

Conditions

Cardiovascular Disease

Keywords

vitamin D; 25-hydroxyvitamin D; 1,25-dihydroxyvitamin D; MACCE; mortality; cardiac; cerebrovascular

Outcome Measures

Primary Outcomes (1)

• major cardiac or cerebrovascular event (MACCE)

  MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.

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

Secondary Outcomes (4)

• duration of ventilatory support

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

• intensive care unit stay

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

• in-hospital stay

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

• infection

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

Study Arms (1)

cardiac surgical patients

patients undergoing a cardiac surgical procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

cardiac surgical patients

You may qualify if:

• cardiac surgical patients aged 18 years and older

You may not qualify if:

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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Heart & Diabetes Center North-Rhine Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

• Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann 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.

  PMID: 23315905 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Armin Zittermann, PhD

  Heart & Diabetes Center North-Rhine Westfalia, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: July 1, 2014
• Last Updated: August 11, 2016

Record last verified: 2014-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)