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MitralPOCS: Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Sponsor
Kuopio University Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03682393
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebohalf of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. atrial fibrillation [three days after mitral valve surgery]

      Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kuopio University Hospital Kuopio Finland 70029

    Sponsors and Collaborators

    • Kuopio University Hospital

    Investigators

    • Principal Investigator: Jari Halonen, MD, PhD, general surgery attending, clinical teacher

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kuopio University Hospital
    ClinicalTrials.gov Identifier:
    NCT03682393
    Other Study ID Numbers:
    • KUH5101126
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Kuopio University Hospital
    postoperative
    atrial fibrillation
    post cardiac surgery
    corticosteroid
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Hydrocortisone

    Study Results

    No Results Posted as of Apr 7, 2022