Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D and Outcome in Cardiac Surgery (Calcitop)

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.
 
ClinicalTrials.gov Identifier: NCT02192528
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

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.

Condition or disease
Cardiovascular Disease

Detailed Description:
In a retrospective data analysis, we will evaluate the association of vitamin D metabolites (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin 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 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will also assess the association of vitamin D metabolite levels 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 3852 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients
Study Start Date : June 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort
cardiac surgical patients
patients undergoing a cardiac surgical procedure



Primary Outcome Measures :
  1. 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 :
  1. duration of ventilatory support [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
  2. intensive care unit stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
  3. in-hospital stay [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]
  4. infection [ Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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): NCT02192528


Locations
Layout table for location information
Germany
Heart & Diabetes Center North-Rhine Westphalia
Bad Oeynhausen, NRW, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Layout table for investigator information
Principal Investigator: Armin Zittermann, PhD Heart & Diabetes Center North-Rhine Westfalia, Germany
Publications:
Layout table for additonal information
Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT02192528    
Other Study ID Numbers: 008
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: July 2014
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
1,25-dihydroxyvitamin D
MACCE
mortality
cardiac
cerebrovascular
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases