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MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
intravenous magnesium
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria: patient undergoing coronary artery bypass surgery with or without valve procedure scheduled for on-pump or cardiopulmonary bypass protocol Exclusion Criteria: existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications ventricular fibrillation sustained ventricular tachycardia 2nd or 3rd degree heart block paroxysmal supraventricular tachycardia major aortic repair planned during open-heart procedure permanent atrial/ventricular pacemaker implanted dialysis dependent or creatinine clearance < 35 umoles/min or oliguric/anuric renal failure patient intolerant of beta blockers patient has reactive airways disease dependent on regular beta-adrenergic agents patient is scheduled to undergo off-pump surgical protocol

Sites / Locations

  • Vancouver General Hospital
  • St. Paul's Hospital

Outcomes

Primary Outcome Measures

atrial fibrillation

Secondary Outcome Measures

stroke
death
myocardial infarction

Full Information

First Posted
November 7, 2005
Last Updated
November 3, 2010
Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00250965
Brief Title
MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
Official Title
Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
Terminated by DSMB; futility analysis showing Mg treatment not efficacious
Study Start Date
July 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. A large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. In addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.
Detailed Description
All patients referred for non-emergent cardiac surgery for isolated CABG, isolated valvular heart surgery, or combined valvular and CABG surgery are eligible for the study. Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily. Atrial fibrillation (and other arrhythmias) will be detected by placing all subjects on continuous 24-hour ECG telemetry monitoring for postoperative days 0 through 4. The study is powered to detect at least a 30% relative reduction in postoperative atrial fibrillation in the CABG group; n=756. Because of the higher incidence of atrial fibrillation in the Valve +/- CABG group a total of 500 patients will be required to detect at least a 30% difference between treatment groups. These sample sizes are based on an alpha of 0.05 and 80% power.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
927 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous magnesium
Intervention Description
Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily.
Primary Outcome Measure Information:
Title
atrial fibrillation
Time Frame
0-4 days after surgery
Secondary Outcome Measure Information:
Title
stroke
Time Frame
0-4 days after surgery
Title
death
Time Frame
0-4 days after surgery
Title
myocardial infarction
Time Frame
4 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient undergoing coronary artery bypass surgery with or without valve procedure scheduled for on-pump or cardiopulmonary bypass protocol Exclusion Criteria: existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications ventricular fibrillation sustained ventricular tachycardia 2nd or 3rd degree heart block paroxysmal supraventricular tachycardia major aortic repair planned during open-heart procedure permanent atrial/ventricular pacemaker implanted dialysis dependent or creatinine clearance < 35 umoles/min or oliguric/anuric renal failure patient intolerant of beta blockers patient has reactive airways disease dependent on regular beta-adrenergic agents patient is scheduled to undergo off-pump surgical protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin H Humphries, DSc
Organizational Affiliation
University of British Columbia/St. Paul's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hubert Wong, PhD
Organizational Affiliation
University of British Columbia, Department of Health Care & Epidemiology
Official's Role
Study Chair
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

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MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery

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