Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Improvement in cardiac output (measured by Doppler method) defined by an increase of more than 10% 24 hours after administration of the treatment in patients admitted and treated by either fluid expansion or furosemide.
研究概览
简要总结
Right ventricular necrosis increases patient in hospital mortality and can be observed in 20-50% of patients admitted for during acute myocardial infarction. Current guidelines recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV load using fluid expansion and if insufficient adding inotropic support. However, several experimental studies reported a potential deleterious effect of right ventricular dilation related to fluid expansion because right and left ventricular interaction decreases stroke volume and cardiac output. Consistently with these finding, a study on a small patient sample conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in patients with right ventricular necrosis.
The present study is a phase 3, interventional, prospective, randomized, multicenter, double-blind analysis by intention to treat.
The main objective is to demonstrate improved hemodynamic parameters in the short term in patients admitted for acute myocardial infarction with extension RV treated with furosemide.
The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide.
The study population will consist in 88 patients and the duration of subjects' participation will be one month.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluid expansion
Placebo furosemide (Glucose 5%) and Vascular filling
The vascular filling is the gold standard in the treatment of acute myocardial infarction
干预措施: Placebo furosemide (Drug)
Furosemide
Furosemide and Placebo filling (Glucose 5%).
干预措施: Furosemide (Drug)
Furosemide
Furosemide and Placebo filling (Glucose 5%).
干预措施: Placebo filling (Drug)
Fluid expansion
Placebo furosemide (Glucose 5%) and Vascular filling
The vascular filling is the gold standard in the treatment of acute myocardial infarction
干预措施: Vascular filling (Drug)
结局指标
主要结局
Improvement in cardiac output (measured by Doppler method) defined by an increase of more than 10% 24 hours after administration of the treatment in patients admitted and treated by either fluid expansion or furosemide.
时间窗: At Hour 24
次要结局
- Rate of inotropic support(an average of 10 days after inclusion)
- Change in systolic blood(Hour 24)
- Number of hemodynamic instability requiring fluid expansion(an average of 10 days after inclusion)
- Change in heart rate(Hour 24)
- Urine output(Hour 24)
- Hospitalizations for cardiovascular reason one month after acute myocardial infarction(month 1)
- Intra-hospital mortality(an average of 10 days after inclusion)
- One month mortality(month 1)
- The duration of hospitalization in intensive care(an average of month 1)