Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

November 15, 2012 updated by: Helena Pehkonen, Kuopio University Hospital

Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial

Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor.

We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.

Exclusion Criteria:

  • Previous episodes of AF or flutter
  • Uncontrolled diabetes mellitus
  • Systemic mycotic infection
  • Active tuberculosis
  • Cushing's syndrome
  • Psychotic mental disorder
  • Herpes Simplex keratitis
  • Serum creatinine exceeding 200 µg/ml
  • Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study couldn´t start due to investigator
Drug: intravenous hydrocortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study couldn´t start due to investigator
Time Frame: Study couldn´t start due to investigator
Study couldn´t start due to investigator
Study couldn´t start due to investigator

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study couldn´t start due to investigator
Time Frame: Study couldn´t start due to investigator
Study couldn´t start due to investigator
Study couldn´t start due to investigator

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study couldn´t start due to investigator
Time Frame: Study couldn´t start due to investigator
Study couldn´t start due to investigator
Study couldn´t start due to investigator

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

Collaborators

Oulu University Hospital
Tampere University Hospital

Investigators

  • Principal Investigator: Jari Halonen, MD, Kuopio University Hospital

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

October 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (Estimate)

March 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5204515

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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