Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Study Overview
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Brief Summary
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The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.

Detailed Description
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Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.

Official Title
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Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: open mitral valve surgery patients agrees to participate in the study adult (minimum 18 years of age) Exclusion Criteria: atrial fibrillation onset before first postoperative morning prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day) patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment systemic mucous infections known allergy or oversensitivity to hydrocortisone Cushing syndrome history of psychosis history of ulcus or active ulcus chronic atrial fibrillation or atrial flutter corticosteroid or immunosuppressive treatment in use for any reason active tuberculosis infection severe renal impairment (serum creatinine 200 umol/l or over) history of deep or superficial venous trombosis Herpes simplex -ceratitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset | Drug: Hydrocortisone<br>* 100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset<br>* Other names: corticosteroid;|
| Placebo Comparator: Placebos<br>100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset | Drug: Placebos<br>* 100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset<br>* Other names: placebo, saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation | Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery. | three days after mitral valve surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, atrial fibrillation, post cardiac surgery, corticosteroid