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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965874
• Other study ID #: LOMAGHI
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2009
• Last updated: April 18, 2018
• Start date: November 2009
• Est. completion date: August 2014

Study information

• Verified date: April 2018
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Magnesium Sulfate high dose
9 g infusion once during 30 minutes
• Magnesium Sulfate low dose
4.5 g magnesium sulfate infusion
• Placebos
serum salin

Locations

Country	Name	City	State
Tunisia	University Hospital of Monastir	Monastir	Monstir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HR <90 bpm or 20% reduction from baseline at 24 hours		24 hours
Secondary	Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)		24 hours