Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation : Randomised Controlled Double Blind Study (LOMAGHI Study)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Magnesium Sulfate high dose
* Drug: Magnesium Sulfate low dose
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Sulfate high dose infusion<br>9 g Magnesium sulfate infusion over 30 minutes | Drug: Magnesium Sulfate high dose<br>* 9 g infusion once during 30 minutes<br>* Other names: Magnesium Sulfate;|
| Active Comparator: Magnesium Sulfate low dose infusion<br>4.5 magnesium sulfate infusion over 30 minutes | Drug: Magnesium Sulfate low dose<br>* 4.5 g magnesium sulfate infusion<br>* Other names: Magnesium Sulfate;|
| Placebo Comparator: placebo<br>serum salin | Drug: Placebos<br>* serum salin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR <90 bpm or 20% reduction from baseline at 24 hours |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……) |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Atrial Fibrillation, Magnesium Sulfate, Cardiac arrhythmia