Does postoperative corticosteroid management prevent atrial fibrillation after mitral valve surgery?

Does postoperative corticosteroid management prevent atrial fibrillation after mitral valve surgery? - Does postoperative corticosteroid management prevent atrial fibrillation after mitral valve surgery?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001431-40-FI

Enrollment

240

Registered

2018-07-30

Start date

2018-08-01

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

new onset atrial fibrallation and paroxysmal atrial fibrillation

Interventions

Trade Name: Solu-Cortef 100mg inj kuiva-aine ja liuotin liuosta varten Product Name: Solu-Cortef Product Code: 420596 Pharmaceutical Form: Concentrate and solvent for solution for infusion Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: mitral valve surgery (plasty or prostesis), adult, willing to participate, not in chronic atrial fibrillation preoperatively Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: not willing to participate, insulin dependent diabetes, active ulcus, oversensitivity or allergy to hydrocortison, chronic atrial fibrillation, psychosis, prolonged stay in intensive care unit postoperatively

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to investigate wether postopetavine corticosteroid management prevents new-onset atrial fibrillation or activation of paroxysmal atrial fibrallation immediately after mitral valve surgery.;Secondary Objective: Not applicable;Primary end point(s): patient stays in sinus rhytm for 3 days post mitral valve surgery or patient gets atrial fibrillation during first three postoperative days after mitral valve surgery;Timepoint(s) of evaluation of this end point: 3 postoperative days	—

Measure

Time frame

Main Objective: The main objective of the trial is to investigate wether postopetavine corticosteroid management prevents new-onset atrial fibrillation or activation of paroxysmal atrial fibrallation immediately after mitral valve surgery.;Secondary Objective: Not applicable;Primary end point(s): patient stays in sinus rhytm for 3 days post mitral valve surgery or patient gets atrial fibrillation during first three postoperative days after mitral valve surgery;Timepoint(s) of evaluation of this end point: 3 postoperative days

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Australia, Estonia, Finland

Contacts

Public Contacttutkijalääkäri Saana Palomurto

Kuopio University Hospital

saana.palomurto@kuh.fi358447179351

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026