Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

This study has been terminated.
(Study has been completed as planned)
Sponsor:
Collaborators:
Tampere University Hospital
Oulu University Hospital
Information provided by (Responsible Party):
Helena Pehkonen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00442494
First received: March 1, 2007
Last updated: November 15, 2012
Last verified: October 2012

March 1, 2007
November 15, 2012
October 2012
October 2012   (final data collection date for primary outcome measure)
Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ] [ Designated as safety issue: No ]
Study couldn´t start due to investigator
Not Provided
Complete list of historical versions of study NCT00442494 on ClinicalTrials.gov Archive Site
Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ] [ Designated as safety issue: No ]
Study couldn´t start due to investigator
Not Provided
Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ] [ Designated as safety issue: No ]
Study couldn´t start due to investigator
Not Provided
 
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Atrial Fibrillation
Drug: intravenous hydrocortisone
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Intervention: Drug: intravenous hydrocortisone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00442494
KUH5204515
No
Helena Pehkonen, Kuopio University Hospital
Kuopio University Hospital
  • Tampere University Hospital
  • Oulu University Hospital
Principal Investigator: Jari Halonen, MD Kuopio University Hospital
Kuopio University Hospital
October 2012

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