Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Magnesium Sulfate high dose
Magnesium Sulfate low dose
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Rapid Atrial Fibrillation, Magnesium Sulfate, Cardiac arrhythmia
Eligibility Criteria
Inclusion Criteria:
- All patients presenting to ED with rapid AF (Heart rate >120 bpm).
Exclusion Criteria:
- Unstable hemodynamic state.
- Renal insufficiency (creatinemia> 180 µmol/l).
- Allergy to MgS.
Sites / Locations
- University Hospital of Monastir
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Magnesium Sulfate high dose infusion
Magnesium Sulfate low dose infusion
placebo
Arm Description
9 g Magnesium sulfate infusion over 30 minutes
4.5 magnesium sulfate infusion over 30 minutes
serum salin
Outcomes
Primary Outcome Measures
HR <90 bpm or 20% reduction from baseline at 24 hours
Secondary Outcome Measures
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00965874
Brief Title
Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation
Official Title
Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation : Randomised Controlled Double Blind Study (LOMAGHI Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
Detailed Description
Introduction:
Atrial fibrillation (AF) is a potentially life-threatening cardiac arrhythmia and a frequent chief complaint in emergency departments (ED). It is an important concern for a substantial proportion of people worldwide. According to the Rotterdam study, the prevalence of AF among individuals aged between 55 to 59 years is estimated at 1.1 for 1000 persons/year and 20.7 for individuals between 80 and 84 years. Given current adult advanced cardiac life support (ACLS), the immediate clinical objective in rapid AF is to achieve ventricular rate control. Digoxin, beta blockers and calcium channel antagonists are the most widely used agents for the emergent treatment of rapid AF. However, their effect is limited because only half of the patients will acutely respond to the first intention treatment. Several studies showed that the magnesium sulfate (MgS) is beneficial in the control of the rate and the rhythm of AF. In addition, hypomagnesemia is present among patients having AF in 20 to 53% of the cases . The association of hypomagnesemia and AF is common after a cardiac surgery and the prophylactic administration of MgS could be useful in post-operative AF .
The last meta analysis published in 2007 showed that the MgS is as well efficient in rate control (OR = 1.96) as in rhythm control (OR = 1.60) of AF. However most studies included in this meta analysis were conducted on limited number of patients (303 patients included for rate control outcome analysis and 376 for rhythm control). Consequently we need further randomized controlled studies to establish definitively the efficacy and the safety of MgS in the early management of rapid AF.
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Rapid Atrial Fibrillation, Magnesium Sulfate, Cardiac arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Sulfate high dose infusion
Arm Type
Experimental
Arm Description
9 g Magnesium sulfate infusion over 30 minutes
Arm Title
Magnesium Sulfate low dose infusion
Arm Type
Active Comparator
Arm Description
4.5 magnesium sulfate infusion over 30 minutes
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
serum salin
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate high dose
Other Intervention Name(s)
Magnesium Sulfate
Intervention Description
9 g infusion once during 30 minutes
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate low dose
Other Intervention Name(s)
Magnesium Sulfate
Intervention Description
4.5 g magnesium sulfate infusion
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
serum salin
Primary Outcome Measure Information:
Title
HR <90 bpm or 20% reduction from baseline at 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients presenting to ED with rapid AF (Heart rate >120 bpm).
Exclusion Criteria:
Unstable hemodynamic state.
Renal insufficiency (creatinemia> 180 µmol/l).
Allergy to MgS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nouira semir, MD
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Monastir
City
Monastir
State/Province
Monstir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation
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