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Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT ID: NCT00442494

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation after cardiac surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Study couldn´t start due to investigator

Study couldn´t start due to investigator

Group Type OTHER

intravenous hydrocortisone

Intervention Type DRUG

Interventions

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intravenous hydrocortisone

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helena Pehkonen

assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jari Halonen, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

References

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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. doi: 10.1001/jama.297.14.1568.

Reference Type DERIVED
PMID: 17426276 (View on PubMed)

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. doi: 10.1001/jama.297.14.1562.

Reference Type DERIVED
PMID: 17426275 (View on PubMed)

Other Identifiers

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KUH5204515

Identifier Type: -

Identifier Source: org_study_id