Post-operative Corticosteroid Treatment After Mitral Valve Surgery (MitralPOCS)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Hydrocortisone; Drug: Placebos

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 Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70029
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocortisone; 100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset	Drug: Hydrocortisone; 100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset; Other Names: corticosteroid
Placebo Comparator: Placebos; 100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset	Drug: Placebos; 100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset; Other Names: placebo, saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atrial fibrillation	Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.	three days after mitral valve surgery

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Investigators: Principal Investigator: Jari Halonen, MD, PhD, general surgery attending, clinical teacher

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: atrial fibrillation; corticosteroid; postoperative; post cardiac surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: KUH5101126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD are not to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No