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

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Hydrocortisone
Placebos
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring postoperative, atrial fibrillation, post cardiac surgery, corticosteroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrocortisone

Placebos

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
March 29, 2022
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03682393
Brief Title
Post-operative Corticosteroid Treatment After Mitral Valve Surgery
Acronym
MitralPOCS
Official Title
Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
the study never started
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
postoperative, atrial fibrillation, post cardiac surgery, corticosteroid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Description
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
corticosteroid
Intervention Description
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
placebo, saline
Intervention Description
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
Primary Outcome Measure Information:
Title
atrial fibrillation
Description
Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.
Time Frame
three days after mitral valve surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Halonen, MD, PhD
Organizational Affiliation
general surgery attending, clinical teacher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD are not to be shared with other researchers.

Learn more about this trial

Post-operative Corticosteroid Treatment After Mitral Valve Surgery

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