Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- atrial fibrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study is double blinded, neither the patients or investigators or nurses managing the drugs do not know whether the patient receives placebo (isotonic saline) or active drug (corticosteroid). In case of emergency the codes can be cracked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open mitral valve surgery
- •patients agrees to participate in the study
- •adult (minimum 18 years of age)
排除标准
- •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
研究组 & 干预措施
Placebos
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
干预措施: Placebos (Drug)
Hydrocortisone
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
atrial fibrillation
时间窗: three days after mitral valve surgery
Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.
次要结局
未报告次要终点