Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- RCT Feasibility
研究概览
简要总结
A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.
详细描述
Most studies of new onset atrial fibrillation (NOAF) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. Parenteral Mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of NOAF in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. The main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Magnesium Sulfate
4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses
干预措施: Magnesium sulfate (Drug)
0.9% NaCl
100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses
干预措施: Placebo (Drug)
结局指标
主要结局
RCT Feasibility
时间窗: 90 days
Recruitment rate of ≥ 2 patients/month/ICU
次要结局
- Functional Outcomes(365 days)
- Equipoise and Feasibility(365 days)
- Acute Care Outcomes(28 days)
- Hospital Outcomes(28 days)
- Adverse Events(28 days)
研究者
Dr. Stephanie Sibley
Assistant Professor
Queen's University