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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:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


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

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
Tampere University Hospital
Oulu 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):

Responsible Party: Helena Pehkonen, assistant, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00442494     History of Changes
Other Study ID Numbers: KUH5204515
Study First Received: March 1, 2007
Last Updated: November 15, 2012
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 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013