Clinical trial NCT03682393: Post-operative Corticosteroid Treatment After Mitral Valve Surgery
Official title: Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Atrial Fibrillation
Keywords: postoperative
atrial fibrillation
post cardiac surgery
corticosteroid
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: atrial fibrillation
timeFrame: three days after mitral valve surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: general surgery attending, clinical teacher
name: Jari Halonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: