Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Phase 2

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Drug: Hydrocortisone; Drug: Placebos

• Registration Number: NCT03682393
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Study Start: 2020-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone	Hydrocortisone	100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
Placebos	Placebos	100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Primary Outcome Measures

Name	Time	Method
atrial fibrillation	three days after mitral valve surgery	Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland