Effect of Corticosteroids on Atrial Fibrillation Incidence After Cardiac Surgery

This study has been terminated.

( Study has been completed as planned )

First Received on March 1, 2007. Last Updated on January 11, 2008 History of Changes

Sponsor:	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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Surgery

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone Sodium Succinate Hydrocortisone cypionate

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

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

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00442494 History of Changes
Other Study ID Numbers:	KUH5204515
Study First Received:	March 1, 2007
Last Updated:	January 11, 2008
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:

Atrial fibrillation after cardiac surgery

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cortisol succinate

Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012