Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Atrial Fibrillation Clinical Trial

— MitralPOCS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03682393
• Other study ID #: KUH5101126
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Hydrocortisone
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
• Placebos
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation	Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.	three days after mitral valve surgery