Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

NCT06802432

Post Operative Arrythmia Anesthesia Cardiac Surgery +1 more

COMPLETED EARLY_PHASE1

Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT00442494

Atrial Fibrillation

TERMINATED NA

Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

NCT00953212

Atrial Fibrillation Atrial Flutter

COMPLETED PHASE3

Management of New-Onset Postoperative Atrial Fibrillation

NCT01395836

Atrial Fibrillation Coronary Artery Disease Post Operative Arrythmia

COMPLETED

Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT00783900

Atrial Fibrillation Biatrial Pacing Metoprolol

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydrocortisone

100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydrocortisone

100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset

Intervention Type DRUG

Placebos

100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

corticosteroid placebo, saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No