Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery - Tabular View

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Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery

This study has been terminated.
Information provided by Kuopio University Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Atrial Fibrillation

Intervention ^†

Drug: intravenous hydrocortisone

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00442494

Organization ID

KUH5204515

Secondary IDs ^††

Study Sponsor ^†

Kuopio University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Jari Halonen, MD

Kuopio University Hospital

Information Provided By

Kuopio University Hospital

Verification Date

January 2008

First Received Date ^†

March 1, 2007

Last Updated Date

January 11, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.