Echocardiography and Lung Ultrasound Combined Into a Rapid Cardiothoracic Ultrasound Protocol (CaTUS) for Guiding Decongestive Treartment on a Day-to-day Basis in Patients Hospitalized for Acute Heart Failure With Pulmonary Congestion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients with re-hospitalization
研究概览
简要总结
A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.
详细描述
Study overview:
The purpose of this study is to evaluate whether ultrasound-guided decongestive therapy, guided by a focused thoracic ultrasound protocol combining echocardiography and lung ultrasound, could result in better decongestion and post-discharge prognosis without lengthening hospitalizations in hospitalized Acute Heart Failure patients.
Primary objectives:
To test whether ultrasound-guided therapy could result in reduced 6-month post-discharge mortality rates or re-hospitalization rates
Secondary objectives:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the treating physician on the ward will know which arm the patient belongs to
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound
- •Elevated natriuretic peptide level
- •Signs of elevated LVEDP on echocardiography
- •Dyspnea at rest or ortophnea
排除标准
- •eGFR <25ml/min/1.73m2 or on dialysis
- •Altered mental orientation
- •Intubated
- •Mitral stenosis or previous mitral valve procedure
- •Chronic pulmonary parenchymal disease Pregnancy/breastfeeding
- •Prisoners
- •Patient under involuntary treatment
- •Decision on study participation not made within 6 hours after receiving information regarding the study
研究组 & 干预措施
Treatment arm
Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound
干预措施: Cardiothoracic ultrasound protocol (Diagnostic Test)
Control Arm
This arm will have the same ultrasound exams done daily as the treatment arm, but information will not be available for the treating physician for guiding therapy
干预措施: Cardiothoracic ultrasound protocol (Diagnostic Test)
结局指标
主要结局
Number of patients with re-hospitalization
时间窗: 6-months, also 3-months will be analyzed
Post-discharge re-hospitalization due to acute heart failure
Number of patients with re-hospitalization or death
时间窗: 6-months, also 3-months will be analyzed
post-discharge combined endpoint of re-hospitalization for acute heart failure or death due to any cause
次要结局
- Number of patients with decongestion(during hospitalization)
研究者
Juha Hartikainen
Clinical Professor
Kuopio University Hospital