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Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

This study has been terminated.
(Study has been completed as planned)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442494
First Posted: March 2, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tampere University Hospital
Oulu University Hospital
Information provided by (Responsible Party):
Helena Pehkonen, Kuopio University Hospital
  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
Atrial Fibrillation Drug: intravenous hydrocortisone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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:


Further study details as provided by Helena Pehkonen, Kuopio University Hospital:

Primary Outcome Measures:
  • Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ]
    Study couldn´t start due to investigator


Secondary Outcome Measures:
  • Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ]
    Study couldn´t start due to investigator


Other Outcome Measures:
  • Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ]
    Study couldn´t start due to investigator


Enrollment: 1
Study Start Date: October 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Drug: intravenous hydrocortisone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442494


Sponsors and Collaborators
Kuopio University Hospital
Tampere University Hospital
Oulu University Hospital
Investigators
Principal Investigator: Jari Halonen, MD Kuopio University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helena Pehkonen, assistant, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00442494     History of Changes
Other Study ID Numbers: KUH5204515
First Submitted: March 1, 2007
First Posted: March 2, 2007
Last Update Posted: October 12, 2017
Last Verified: October 2012

Keywords provided by Helena Pehkonen, Kuopio University Hospital:
Atrial fibrillation after cardiac surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents