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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Monastir
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir
ClinicalTrials.gov Identifier:
NCT00965874
First received: August 24, 2009
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Magnesium Sulfate high dose
Drug: Magnesium Sulfate low dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation : Randomised Controlled Double Blind Study (LOMAGHI Study)

Resource links provided by NLM:


Further study details as provided by University of Monastir:

Primary Outcome Measures:
  • Rhythm control: rate and delay of return to sinusal rhythm. Rate control: reduction of heart rate (HR <100 bpm or 20% reduction from baseline) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium Sulfate high dose infusion
9 g Magnesium sulfate infusion over 30 minutes
Drug: Magnesium Sulfate high dose
9 g infusion once during 30 minutes
Active Comparator: Magnesium Sulfate low dose infusion
4.5 magnesium sulfate infusion over 30 minutes
Drug: Magnesium Sulfate low dose
4.5 g magnesium sulfate infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965874

Contacts
Contact: nouira semir, MD 216532014 semir.nouira@rns.tn

Locations
Tunisia
University Hospital of Monastir Recruiting
Monastir, Monstir, Tunisia, 5000
Contact: semir nouira, Pr    21673460144    semir.nouira@rns.tn   
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: nouira semir, MD University of Monastir
  More Information

No publications provided

Responsible Party: Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT00965874     History of Changes
Other Study ID Numbers: LOMAGHI
Study First Received: August 24, 2009
Last Updated: May 16, 2014
Health Authority: Tunisia: Ministry of Public Health

Keywords provided by University of Monastir:
Rapid Atrial Fibrillation
Magnesium Sulfate
Cardiac arrhythmia

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 22, 2014