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

Tracking Information

First Received Date ^ICMJE

March 1, 2007

Last Updated Date

January 11, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00442494 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: intravenous hydrocortisone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00442494

Responsible Party

Study ID Numbers ^ICMJE

KUH5204515

Study Sponsor ^ICMJE

Kuopio University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jari Halonen, MD

Kuopio University Hospital

Information Provided By

Kuopio University Hospital

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP