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Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00442494
Recruitment Status : Terminated (Study has been completed as planned)
First Posted : March 2, 2007
Last Update Posted : November 16, 2012
Sponsor:
Collaborators:
Tampere University Hospital
Oulu University Hospital
Information provided by (Responsible Party):
Helena Pehkonen, Kuopio University Hospital

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: intravenous hydrocortisone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Drug: intravenous hydrocortisone



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. Study couldn´t start due to investigator [ Time Frame: Study couldn´t start due to investigator ]
    Study couldn´t start due to investigator



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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

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 Posted: March 2, 2007    Key Record Dates
Last Update Posted: November 16, 2012
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