Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulmonary fluid content
研究概览
简要总结
Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure. However, no randomized clinical trials have investigated loop diuretics versus other interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of furosemide is based in studies from the 1970s. In this study, we aim to assess the acute effect of furosemide on cardiac filling pressures and pulmonary congestion.
Hypothesis:
Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac filling pressures and pulmonary congestion before significant diuresis occurs.
Design:
A prospective, interventional study including 20 patients admitted due to a clinical diagnosis of acute heart failure with pulmonary congestion.
Intervention:
80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
详细描述
Prospective observational study of the acute and subacute effects of furosemide in patients with acute heart failure.
After inclusion, 80 mg of furosemide is administered IV.
Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Clinical diagnosis of acute heart failure requiring hospitalization
- •Systolic blood pressure ≥100 mmHg
- •Oxygen saturation <94% or need of oxygen
- •Confirmed pulmonary congestion on x-ray or ReDS
排除标准
- •More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration
- •Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm.
- •Known chronic obstructive lung disease
- •Pacemaker or ICD on the right side
- •Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
- •Wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
- •Height less than 155 cm or higher than 200 cm
- •BMI of less than 18 or more than 38
研究组 & 干预措施
Furosemide
80 mg of furosemide is administered IV
干预措施: Furosemide Injection (Drug)
结局指标
主要结局
Pulmonary fluid content
时间窗: From the time 0 to 30 minutes
Remote dielectric sensing (ReDS) is a non-invasive electromagnetic-based tool that measures absolute lung fluid content and gives the fluid content in a proportional value ranging from 0-100 percent. 20-35% represent normal values. The primary outcome will be change in pulmonary fluid content after administration of furosemide
次要结局
未报告次要终点
研究者
Johannes Grand
Principal Investigator
Copenhagen University Hospital, Hvidovre