Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Number of days alive and out of hospital
研究概览
简要总结
This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.
详细描述
Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality.
The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of:
- •at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea
- •one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP).
- •Patients affiliated to French social security ("AME excepted")
- •Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)
排除标准
- •Patients are excluded if they have any of the followings:
- •other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction)
- •systolic blood pressure less than 100 mmHg
- •severe mitral or aortic stenosis, or severe aortic regurgitation
- •known chronic kidney injury on dialysis
- •shock from any cause
- •Time from ED entrance to inclusion > 6h
- •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
结局指标
主要结局
Number of days alive and out of hospital
时间窗: 30 days
Number of days alive and out of hospital
次要结局
- To evaluate the effect of AHF management on the 30-day cardiovascular death(30 days)
- To evaluate the effect of AHF management on the hospital readmission at 30 days(30 days)
- To evaluate the effect of AHF management on the 30-day all causes death(30 days)
- To evaluate the effect of AHF management on the length of stay in hospital(30 days)
- To evaluate the effect of AHF management on changes of more than 2 fold in creatinine level from randomization to day 30 or to discharge whichever comes first(30 days)