Post-operative Corticosteroid Treatment After Mitral Valve Surgery

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuopio University Hospital
• Treatments: Hydrocortisone

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