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

Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery

This study has been terminated.
( Study has been completed as planned )

Sponsored by:	Kuopio University Hospital
Information provided by:	Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00442494

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: intravenous hydrocortisone	Phase III

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics:

Surgery

ChemIDplus related topics:

Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442494

Sponsors and Collaborators

Kuopio University Hospital

Investigators


Principal Investigator:	Jari Halonen, MD	Kuopio University Hospital

More Information

Publications indexed to this study:

Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76.

Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7.

Study ID Numbers:	KUH5204515
First Received:	March 1, 2007
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00442494
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Kuopio University Hospital:

Atrial fibrillation after cardiac surgery

Study placed in the following topic categories:

Hydrocortisone

Heart Diseases

Cortisol succinate

Hydrocortisone acetate

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Pathologic Processes

Therapeutic Uses

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 18, 2008