MAGNesium and Digoxin Versus AMiodarone for Fast Atrial Fibrillation in the ICU (MAGNAM Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Heart rate control (<110 beats per minute) and/or restoration of normal sinus
研究概览
简要总结
A multi-centre, non-blinded, comparative effectiveness, randomised controlled trial. Patients will be prospectively enrolled from Critical Care Units and will be assessed for study enrollment based on inclusion/exclusion criteria at the time of the onset of fast atrial fibrillation (AF)(irregular and often rapid heart rate). The authors hypothesize that high dose Magnesium Sulphate with the addition of Digoxin as a second line treatment will improve the success rate in returning the heart to normal rhythm as well as speed of resolution of critical illness in new onset rapid atrial fibrillation in the critically ill cared for in general ICUs.
详细描述
This is a Multi-centre, randomised controlled, clinical trial that is comparing a Stepwise Strategy of Magnesium Followed by Digoxin, With an Amiodarone Backup vs a Strategy of First-line Amiodarone to See Which is More Effective in Returning the Heart to Normal Rhythm After Experiencing Rapid Atrial Fibrillation in General ICUs. It will take place in Critical Care Units in Toronto Health Sciences Centres over a course of 2 years. The sample size is 200 patients.
Investigational Product and Planned Use Magnesium sulphate
The trial intervention will be Magnesium sulphate followed by digoxin as second line therapy with Amiodarone as third line. The Standard of care intervention will be Amiodarone as first line treatment in the and then no more than 2g MgSO4 be delivered.
Data will be collected retrospectively at the outcome timepoints.
Statistical Analysis:
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
- Single (Outcomes Assessor)
盲法说明
Blinded follow up for key outcomes
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must meet all of the following inclusion criteria to participate in this study:
- •Admitted to a participating hospital ICU
- •A newly documented episode of fast Atrial Fibrillation with heart rate >120/min confirmed by a 12-lead ECG assessment regardless of baseline rhythm (note- The AF can be acute or chronic diagnosis)
- •Undergoing, or able to commence continuous electrocardiographic monitoring ("telemetry") as part of their routine clinical care
- •Treating physician determines the patient has clinically significant AF that requires medical treatment
排除标准
- •Age <18 years
- •Palliative goals of care or expected to die in the next 12 hours
- •Fast Atrial Fibrillation (>120/min) present for > 48 hours
- •Treatment with digoxin or a class I or III anti-arrhythmic medication within the preceding 24 hours
- •MgSO4 dose of > 3g IV in the last 2 hours.
- •History of high grade Atrio-Ventricular conduction block or bradyarrhythmia without pacemaker
- •Non-cardiac indication or contraindication to one of the study treatments (hypertensive disorders of pregnancy, pre-term labour, neuromuscular junction disorders i.e. known Myasthenia gravis; documented prior history of amiodarone toxicity or relative contraindication such as thyroid disease, cirrhosis, pulmonary fibrosis, etc.)
- •Recent cardiac surgery during index hospital admission
- •Known pregnancy
- •Sustained (more than 10 continuous seconds documented on a rhythm strip) ventricular arrhythmia within the past 24 hours
- •Known or suspected pre-excitation syndrome
- •Persistent hyperkalemia > 6mmol/l despite treatment
- •Previously enrolled in the MAGNAM trial
- •Recent lung transplantation (during this admission)
研究组 & 干预措施
Experimental arm
Intravenous magnesium sulphate as first line followed by digoxin IV loading as second line and then amiodarone IV as third line treatments for fast Atrial Fibrillation
干预措施: Magnesium sulfate and then Digoxin (Drug)
Standard of care arm
Intravenous amiodarone as compactor group intervention
干预措施: Amiodarone (Drug)
结局指标
主要结局
Heart rate control (<110 beats per minute) and/or restoration of normal sinus
时间窗: 6 hours
heart rate control
ICU free days
时间窗: 90 days
ICU free days
次要结局
- Hospital mortality(Up to 90 days)
- Heart rate(24 hours)
- Continuation of trial intervention(Up to 90 days)
- Presence of new rate and / or rhythm control medications at the time of first ICU discharge(Up to 90 days)
- Serious adverse events(Up to 90 days)
- Avoidance of amiodarone(Up to 90 days)