Vitamin D, Cardiac Surgery and Outcome
Vitop
Vitamin D and Clinical Outcome in Cardiac Surgical Patients
1 other identifier
observational
4,418
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedAugust 11, 2016
December 1, 2013
Same day
February 7, 2012
August 10, 2016
Conditions
Keywords
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 (3)
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
Study Arms (1)
cardiac surgical patients
patients undergoing a cardiac surgical procedure
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Heart and Diabetes Center NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Heart Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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: 23315905RESULT
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Armin Zittermann, PhD
Georgstrasse 11, 32545 Bad Oenyhausen, Heart Center NRW, Ruhr University Bochum
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
March 13, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
August 11, 2016
Record last verified: 2013-12
Data Sharing
- IPD Sharing
- Will not share