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临床试验/NCT00965874
NCT00965874已完成3 期

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

University of Monastir1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
450
试验地点
1
主要终点
HR <90 bpm or 20% reduction from baseline at 24 hours

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients presenting to ED with rapid AF (Heart rate >120 bpm).

排除标准

  • Unstable hemodynamic state.
  • Renal insufficiency (creatinemia> 180 µmol/l).
  • Allergy to MgS.

研究组 & 干预措施

Magnesium Sulfate high dose infusion

Experimental

9 g Magnesium sulfate infusion over 30 minutes

干预措施: Magnesium Sulfate high dose (Drug)

Magnesium Sulfate low dose infusion

Active Comparator

4.5 magnesium sulfate infusion over 30 minutes

干预措施: Magnesium Sulfate low dose (Drug)

placebo

Placebo Comparator

serum salin

干预措施: Placebos (Drug)

结局指标

主要结局

HR <90 bpm or 20% reduction from baseline at 24 hours

时间窗: 24 hours

次要结局

  • Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

Professor

University of Monastir

研究点 (1)

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