Vitamin D and Outcome in Cardiac Surgery (Calcitop)

August 10, 2016 updated by: Heart and Diabetes Center North-Rhine Westfalia

25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

3852

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Heart & Diabetes Center North-Rhine Westphalia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

cardiac surgical patients

Description

Inclusion Criteria:

  • cardiac surgical patients aged 18 years and older

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients will be followed for an average time of 14 days from cardiac surgery to discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of ventilatory support
Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
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
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
Patients will be followed for an average time of 14 days from cardiac surgery to discharge
infection
Time Frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
Patients will be followed for an average time of 14 days from cardiac surgery to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

  • Principal Investigator: Armin Zittermann, PhD, Heart & Diabetes Center North-Rhine Westfalia, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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