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

NCT00250965 | Terminated Phase 3

• 1 other identifier: 20R20015
• Study Type: interventional
• Target: 927
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• atrial fibrillation

  0-4 days after surgery

Secondary Outcomes (3)

• stroke

  0-4 days after surgery

• death

  0-4 days after surgery

• myocardial infarction

  4 days after surgery

Interventions

intravenous magnesium DRUG

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient undergoing coronary artery bypass surgery with or without valve procedure
• scheduled for on-pump or cardiopulmonary bypass protocol

You may not qualify if:

• existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications
• ventricular fibrillation
• sustained ventricular tachycardia
• nd 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

Sponsors & Collaborators

• University of British Columbia: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L7, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Karin H Humphries, DSc

  University of British Columbia/St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

• Hubert Wong, PhD

  University of British Columbia, Department of Health Care & Epidemiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: July 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2009
• Last Updated: November 4, 2010

Record last verified: 2009-03

Locations

CA (2)