Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- length of hospital stay (days)
研究概览
简要总结
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.
详细描述
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. The use of hand carried ultrasound is expected to reduce hospital Length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. The hypothesis tested is as follows:
Null: The use of hand carried ultrasound in the management of heart failure patients did not change outcome.
Alternative: The use of hand carried ultrasound in the management of heart failure patients did change outcome.
The study endpoints are as follows:
- A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
- The secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure.
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
- 是
入选标准
- •New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
- •Heart failure NYHA class III, IV
- •Age>=18 years old
排除标准
- •End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
- •end stage Heart failure on chronic inotrope (example Milrinone)
- •Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
- •morbid obesity BMI > 40
- •incarcerated patients (prison) TDC.
- •pregnant patients
- •Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
- •Aged less than 18 years.
结局指标
主要结局
length of hospital stay (days)
时间窗: Immediately after discharge
number of days from admission to discharge
次要结局
- Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days(One month after discharge)
- number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge.(One month after original discharge)
- percent change in GFR(One month after original discharge)
- hospitalization Cost(immediately after discharge of hospitalization)
- Time to readmission(assessed within 4 weeks from index admission (i.e. thirty days readmission))
- Number of right heart catheterization in each group and percentage of right heart catheterization in each group(One month after admission)