Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250965
Status:
TERMINATED
Last Update Posted:
2010-11-04
First Post:
2005-11-07
Brief Title:
MPAACS Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by DSMB futility analysis showing Mg treatment not efficacious
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 n756 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 005 and 80 power
The study is powered to detect at least a 30 relative reduction in postoperative atrial fibrillation in the CABG group n756 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 005 and 80 power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None