Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 8
- 主要终点
- In-hospital Mortality
研究概览
简要总结
Acute pulmonary edema (APE) is a common condition in the emergency room, associated with considerable mortality. The use of intravenous morphine in the treatment of APE remains controversial and Benzodiazepines have been suggested as an alternative for morphine to relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE.
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
- None
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
- •Patients with acute pulmonary edema with dyspnoea and anxiety
排除标准
- •Patients with known severe liver disease.
- •Patients with known severe renal disease.
- •Patients with expectation of death from other illness during the course of the trial.
研究组 & 干预措施
midazolam
The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.
干预措施: Midazolam (Drug)
morphine
The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE
干预措施: Morphine (Drug)
结局指标
主要结局
In-hospital Mortality
时间窗: 28 days after of the hospitalization
In hospital mortality
次要结局
- Length of Hospital Stay(Up to 30 days)
- Number of Participants That Required Invasive Mechanical Ventilation(Up to 1 week)
研究者
Alberto Dominguez-Rodriguez
Alberto Domínguez- Rodríguez, MD, PhD, FESC
Hospital Universitario de Canarias